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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The DGH1006 is a straight corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
DGH TECHNOLOGY INC.
DGH 1006
In Commercial Distribution

  • 00857377006209 ()


  • Ophthalmic ultrasound imaging transducer
The DET2006 is a small, removable probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
DGH TECHNOLOGY INC.
DET 2006
In Commercial Distribution

  • 00857377006247 ()


  • Ophthalmic ultrasound imaging transducer
The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.
HISTOLOGICS, LLC
SFT-4200
In Commercial Distribution

  • 00860275000361 ()
  • 10860275000368 ()


  • Wound debridement tool
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126 B
In Commercial Distribution

  • D801SP65126B1 ()
65-126

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126
In Commercial Distribution

  • D801SP651261 ()
65-126

  • Dentine adhesive
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 86 Basic
In Commercial Distribution

  • 08800018422502 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 without rotation
In Commercial Distribution

  • 08800018421406 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 Basic
In Commercial Distribution

  • 08800018421307 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 Samsung
In Commercial Distribution

  • 08800018421109 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 Compact
In Commercial Distribution

  • 08800018421000 ()


  • X-ray film cassette holder
The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
DRTECH Corporation
LLD 129 with rotation
In Commercial Distribution

  • 08800018420706 ()


  • X-ray film cassette holder
The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.
GENERAL MEDICAL MERATE SPA
X-RAY R&F REMOTE SYSTEM OPERA SWING
In Commercial Distribution

  • 08054890480000 ()

  • Weight: 1120 Kilogram


  • Stationary general-purpose fluoroscopic x-ray system, digital
The Smartlipo Laser is a Nd:YAG laser system. it emits a 1064nm wavelength. Laser emission activation is by foot switch.
EL.EN. SPA
M053Z1
In Commercial Distribution

  • 08057017760474 ()
M053Z1

  • General/multiple surgical solid-state laser system
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part B.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSB
In Commercial Distribution

  • D798BLSB0 ()
BLSB

  • Orthodontic bracket adhesive
H. pylori 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

  • B502BSB56080 ()
BSB 5608

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent
H. pylori 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

  • B502BSB56070 ()
BSB 5607

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent
Helicobacter pylori 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

  • B502BSB56060 ()
BSB 5606

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagent
Granzyme B 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

  • B502BSB55940 ()
BSB 5594

  • Granzyme B IVD, antibody
Granzyme B 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

  • B502BSB55920 ()
BSB 5592

  • Granzyme B IVD, antibody
Granzyme B 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

  • B502BSB55910 ()
BSB 5591

  • Granzyme B IVD, antibody
Granzyme B 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

  • B502BSB55900 ()
BSB 5590

  • Granzyme B IVD, antibody
Granzyme B 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

  • B502BSB55890 ()
BSB 5589

  • Granzyme B IVD, antibody
Tinto Glucagon 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

  • B502BSB55750 ()
BSB 5575

  • Glucagon IVD, antibody
Tinto GH 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

  • B502BSB55680 ()
BSB 5568

  • Human growth hormone (HGH) IVD, antibody
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, 1 ml
In Commercial Distribution

  • B502BSB55380 ()
BSB 5538

  • Follicle stimulating hormone (FSH) IVD, antibody
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
Tinto Calcitonin 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

  • B502BSB51130 ()
BSB 5113

  • Calcitonin IVD, antibody
Tinto A-1-Antitrypsin 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

  • B502BSB50100 ()
BSB 5010

  • Alpha-1-antitrypsin (protease inhibitor) IVD, antibody
Tinto A-1-Antitrypsin 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

  • B502BSB50090 ()
BSB 5009

  • Alpha-1-antitrypsin (protease inhibitor) IVD, antibody
A-1-Antichymotrypsin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buff er pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB50030 ()
BSB 5003

  • Alpha-1-antichymotrypsin IVD, antibody
A-1-Antichymotrypsin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buff er pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB50020 ()
BSB 5002

  • Alpha-1-antichymotrypsin IVD, antibody
Granzyme B 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

  • B502BSB55930 ()
BSB 5593

  • Granzyme B IVD, antibody
Tinto Gastrin 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

  • B502BSB55480 ()
BSB 5548

  • Gastrin IVD, antibody
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 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
CD105/Endoglin 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

  • B502BSB62660 ()
BSB 6266

  • CD105 endoglin marker IVD, antibody
Tinto Synaptophysinn 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

  • B502BSB59470 ()
BSB 5947

  • Synaptophysin IVD, antibody
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
CD105/Endoglin 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

  • B502BSB62650 ()
BSB 6265

  • CD105 endoglin marker IVD, antibody
CD105/Endoglin 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

  • B502BSB62640 ()
BSB 6264

  • CD105 endoglin marker IVD, antibody
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