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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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FSH MMab - B502BSB55360

FSH is a mouse monoclonal antibody from supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB55360 ()
BSB 5536

  • Follicle stimulating hormone (FSH) IVD, antibody

Uroplakin III RPab - B502BSB22910

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB22910 ()
BSB 2291

  • Uroplakin IVD, antibody

Uroplakin III RPab - B502BSB22900

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB22900 ()
BSB 2290

  • Uroplakin IVD, antibody

Uroplakin III RPab - B502BSB22890

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB22890 ()
BSB 2289

  • Uroplakin IVD, antibody

Tinto Uroplakin III RPab - B502BSB22880

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB22880 ()
BSB 2288

  • Uroplakin IVD, antibody

Tinto Uroplakin III RPab - B502BSB22870

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB22870 ()
BSB 2287

  • Uroplakin IVD, antibody

Tinto Uroplakin III RPab - B502BSB22860

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB22860 ()
BSB 2286

  • Uroplakin IVD, antibody

Tinto C1q, RPab - B502BSB30210

Tinto C1q is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB30210 ()
BSB 3021

  • Complement component C1q IVD, antibody

Mycobacterium tuberculosis RPab - B502BSB29970

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB29970 ()
BSB 2997

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Mycobacterium tuberculosis RPab - B502BSB29960

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB29960 ()
BSB 2996

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Mycobacterium tuberculosis RPab - B502BSB29950

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB29950 ()
BSB 2995

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Tinto Mycobacterium tuberculosis RPab - B502BSB29940

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute,15 ml
In Commercial Distribution

  • B502BSB29940 ()
BSB 2994

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Tinto Mycobacterium tuberculosis RPab - B502BSB29930

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB29930 ()
BSB 2993

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Tinto Mycobacterium tuberculosis RPab - B502BSB29920

Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB29920 ()
BSB 2992

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Treponema pallidum, RPab - B502BSB32370

Treponema pallidum is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB32370 ()
BSB 3237

  • Treponema pallidum antigen IVD, antibody

Treponema pallidum, RPab - B502BSB32360

Treponema pallidum is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB32360 ()
BSB 3236

  • Treponema pallidum antigen IVD, antibody

Treponema pallidum, RPab - B502BSB32350

Treponema pallidum is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB32350 ()
BSB 3235

  • Treponema pallidum antigen IVD, antibody

Tinto Treponema pallidum, RPab - B502BSB32340

Treponema pallidum is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB32340 ()
BSB 3234

  • Treponema pallidum antigen IVD, antibody

Tinto Treponema pallidum, RPab - B502BSB32330

Treponema pallidum is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB32330 ()
BSB 3233

  • Treponema pallidum antigen IVD, antibody

Tinto Treponema pallidum, RPab - B502BSB32320

Treponema pallidum is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB32320 ()
BSB 3232

  • Treponema pallidum antigen IVD, antibody

Tinto hPL, RPab - B502BSB68020

Tinto hPL is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB68020 ()
BSB 6802

  • Human placental lactogen (HPL) IVD, antibody

Tinto hPL,RPab - B502BSB68010

Tinto hPL is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB68010 ()
BSB 6801

  • Human placental lactogen (HPL) IVD, antibody

Tinto hPL, RPab - B502BSB68000

Tinto hPL is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB68000 ()
BSB 6800

  • Human placental lactogen (HPL) IVD, antibody

Tinto Claudin-1 RPab - B502BSB65640

Tinto Claudin-1 is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB65640 ()
BSB 6564

  • Claudin protein IVD, antibody

Tinto Claudin-1 RPab - B502BSB65630

Tinto Claudin-1 is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB65630 ()
BSB 6563

  • Claudin protein IVD, antibody

Tinto Claudin-1 RPab - B502BSB65620

Tinto Claudin-1 is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB65620 ()
BSB 6562

  • Claudin protein IVD, antibody

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - NRP368

The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution

  • NRP368 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - NRP130

The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-154
Not in Commercial Distribution

  • NRP130 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French


  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter - NRP014

The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-014R
Not in Commercial Distribution

  • NRP014 ()

  • Catheter Working Length: 150 Centimeter
  • Catheter Gauge: 3.5 French
  • Lumen/Inner Diameter: .014 Inch
R-014R

  • Intravascular ultrasound imaging catheter, reprocessed

EchoMark LP - B53620001

EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
2000
In Commercial Distribution

  • B53620001 ()

  • Small


  • Radiological image marker, implantable

Freevent Connection strap - 07331791008238

Freevent Connection Strap is a clip with a string that is used to secure Freevent DualCare to the patient’s neckband.
Atos Medical AB
7746
In Commercial Distribution

  • 07331791016530 ()
  • 07331791008238 ()
7746

  • Tracheostomy tube speech valve

Capo Natural Set - ESDG2320551

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232055
In Commercial Distribution

  • ESDG2320551 ()


  • Dental composite resin

Capo Natural Bleach 2, 4 g - ESDG2320531

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232053
In Commercial Distribution

  • ESDG2320531 ()


  • Dental composite resin

Capo Natural Bleach 1, 4 g - ESDG2320521

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232052
In Commercial Distribution

  • ESDG2320521 ()


  • Dental composite resin

Capo Natural Incisal white, 4 g - ESDG2320511

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232051
In Commercial Distribution

  • ESDG2320511 ()


  • Dental composite resin

Capo Natural Incisal clear, 4 g - ESDG2320501

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232050
In Commercial Distribution

  • ESDG2320501 ()


  • Dental composite resin

Capo Natural Incisal medium, 4 g - ESDG2320491

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232049
In Commercial Distribution

  • ESDG2320491 ()


  • Dental composite resin

Capo Natural C 3, 4 g - ESDG2320481

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232048
In Commercial Distribution

  • ESDG2320481 ()


  • Dental composite resin

Capo Natural C 2, 4 g - ESDG2320471

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232047
In Commercial Distribution

  • ESDG2320471 ()


  • Dental composite resin

Capo Natural B 3, 4 g - ESDG2320461

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232046
In Commercial Distribution

  • ESDG2320461 ()


  • Dental composite resin

Capo Natural B 2, 4 g - ESDG2320451

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232045
In Commercial Distribution

  • ESDG2320451 ()


  • Dental composite resin

Capo Natural A 4, 4 g - ESDG2320441

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232044
In Commercial Distribution

  • ESDG2320441 ()


  • Dental composite resin

Capo Natural A 3, 4 g - ESDG2320421

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232042
In Commercial Distribution

  • ESDG2320421 ()


  • Dental composite resin

Capo Natural A 1, 4 g - ESDG2320401

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques
Schütz Dental GmbH
232040
In Commercial Distribution

  • ESDG2320401 ()


  • Dental composite resin

Capo Natural A 3.5, 4 g - ESDG2320431

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232043
In Commercial Distribution

  • ESDG2320431 ()


  • Dental composite resin

Capo Natural A 2, 4 g - ESDG2320411

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232041
In Commercial Distribution

  • ESDG2320411 ()


  • Dental composite resin

FlowSense - 13770016085011

FlowSense (ref: A0000047) is the single use sensor used with EOlife (ref: AUS00055). FlowSense is the consumable of EOlife. FlowSense is sold in boxes of 10 units under the sales reference A0000044.
ARCHEON
A0000047
In Commercial Distribution

  • 13770016085011 ()
  • 23770016085018 ()


  • Pulmonary resuscitator, manual, single-use

Myron L® Company - 00857744006122

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, Gallon
In Commercial Distribution

  • 00857744006122 ()

  • Total Volume: 1 Gallon
NACL-14.0G

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006115

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, Quart
In Commercial Distribution

  • 00857744006115 ()

  • Total Volume: 1 Quart
NACL-14.0Q

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006108

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, 2 Ounces
In Commercial Distribution

  • 00857744006108 ()

  • Total Volume: 2 Fluid Ounce
NACL-14.02OZ

  • Haemodialysis conductivity standard solution
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