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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Calcitonin is a rabbit monoclonal antibody that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB64080 ()
BSB 6408

  • Calcitonin IVD, antibody
Bear 2 body is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Foreo AB
Evergreen
In Commercial Distribution

  • 07350120791863 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Bear 2 body is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Foreo AB
Lavender
In Commercial Distribution

  • 07350120791856 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
ID Glide is a water based personal lubricant and is compatible with Latex and Polyurethane Condoms,
WESTRIDGE LABORATORIES INCORPORATED
ID Glide 10 ml Resealable Tube
In Commercial Distribution

  • 00761236110306 ()
  • 00761236109508 ()
  • 90761236109501 ()
IDDGLR10

  • Sexual lubricant
Band-Lok® paste in syringe is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing syringe version. The adhesive is natural shade. This is a Non-Fluoride Device
RELIANCE ORTHODONTIC PRODUCTS INC
NFSMBL
In Commercial Distribution

  • D798NFSMBL0 ()
NFSMBL

  • Dental composite resin
Band-Lok® paste in syringe is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing syringe version. The adhesive is natural shade. This is a Non-Fluoride Device
RELIANCE ORTHODONTIC PRODUCTS INC
1NFSMBL
In Commercial Distribution

  • D7981NFSMBL0 ()
1NFSMBL

  • Dental composite resin
The PatientTouch Blood Product Administration is a software application that helps support nurse documentation of blood product administrations. Additionally, through the use of bar code technology, the solution will electronically acknowledge a match between the blood unit to be administered and the patient. The software It is limited to use in acute care hospitals by licensed, trained, and registered nursing professionals.
PATIENTSAFE SOLUTIONS, INC.
3.3.1
In Commercial Distribution

  • 00853209005006 ()
PTA BPA

  • Blood bank information system application software
Middlebrook 7H9 Broth, 125ml. Hardy Diagnostics Middlebrook 7H9 Broth are recommended for use in the cultivation of Mycobacterium spp. Product is light sensitive.
HARDY DIAGNOSTICS
C24
In Commercial Distribution

  • 00819398020558 ()
  • 00819398020565 ()
C24

  • Enriched broth culture medium IVD
The Thermaeye Plus is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
EL.EN. SPA
M081AN1
In Commercial Distribution

  • 08057017760443 ()
M081AN1

  • Multi-modality skin/body contouring system
The Minisilk-FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
EL.EN. SPA
M081R1
In Commercial Distribution

  • 08057017760337 ()
M081R1

  • Multi-modality skin/body contouring system
This reagent is used in direct antiglobulin tests where the detection of C3 (as C3b or C3d) is required. This product configuration is a single vial.
IMMUCOR, INC.
0004068
In Commercial Distribution

  • 10888234000402 ()
0004068

  • Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody
The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable.
Qt Medical, Inc.
QTPOS124U
In Commercial Distribution

  • 04719872980483 ()


  • Electrocardiographic electrode, single-use
The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable.
Qt Medical, Inc.
QTPOS123U
In Commercial Distribution

  • 04719872980476 ()


  • Electrocardiographic electrode, single-use
The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable.
Qt Medical, Inc.
QTPOS122U
In Commercial Distribution

  • 04719872980469 ()


  • Electrocardiographic electrode, single-use
The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable.
Qt Medical, Inc.
QTPOS121U
In Commercial Distribution

  • 04719872980452 ()


  • Electrocardiographic electrode, single-use
The support is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299915ND
Not in Commercial Distribution

  • M248299915ND1 ()
  • 10381780042488 ()


  • Device sterilization/disinfection container, reusable
The basis is part of the container which product number is 188202ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
188212ND
Not in Commercial Distribution

  • M248188212ND1 ()
  • 10381780042358 ()


  • Device sterilization/disinfection container, reusable
It is hair grow system for OTC
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000B
In Commercial Distribution

  • 06928798600353 ()


  • Hair growth laser device
Crushield is a pouch pill crushing system.
MAXPERT MEDICAL
BCS01
In Commercial Distribution

  • 00852359007342 ()
  • 00852359007397 ()

  • Length: 11 Inch
  • Width: 4.25 Inch
  • Height: 5.5 Inch
BCS01

  • Pill crusher/splitter
A silicone lubricant that is latex compatible.
WESTRIDGE LABORATORIES INCORPORATED
Silicone Lubricant
In Commercial Distribution

  • 30688504003454 ()
  • 00688504003453 ()

  • Total Volume: 4 Fluid Ounce


  • Sexual lubricant
69 Tomes Upper/Lower Roots, IS Forceps
HU-FRIEDY MFG. CO., LLC
F69IS
In Commercial Distribution

  • 10889950113063 ()


  • Tooth extraction forceps
88L Nevius Upper Molar, Left, IS Frcps
HU-FRIEDY MFG. CO., LLC
F88LIS
In Commercial Distribution

  • 10889950113032 ()


  • Tooth extraction forceps
88R Nevius Upper Molar, Right, IS Frcps
HU-FRIEDY MFG. CO., LLC
F88RIS
In Commercial Distribution

  • 10889950113025 ()


  • Tooth extraction forceps
Aer X is a portable Oxygen concentrator
3B MEDICAL, INC.
Aer X
In Commercial Distribution

  • 00853041003000 ()
021000M

  • Mobile/portable oxygen concentrator
Aurix XL is a phlebotomy convenience kit
Nuo Therapeutics, Inc.
AUXP-2T
In Commercial Distribution

  • 00852714003187 ()


  • Phlebotomy kit
A silicone lubricant that is latex compatible.
WESTRIDGE LABORATORIES INCORPORATED
Lush 4 fl oz Silicone Lubricant
In Commercial Distribution

  • 40864785000253 ()
  • 00864785000255 ()


  • Sexual lubricant
A silicone lubricant that is latex compatible.
WESTRIDGE LABORATORIES INCORPORATED
Lush 17 fl oz Silicone Lubricant
In Commercial Distribution

  • 30864785000232 ()
  • 00864785000231 ()


  • Sexual lubricant
A silicone lubricant that is latex compatible.
WESTRIDGE LABORATORIES INCORPORATED
Lush 8.5 fl oz Silicone Lubricant
In Commercial Distribution

  • 30864785000225 ()
  • 00864785000224 ()


  • Sexual lubricant
This product is a weak bleach solution.
RANDOX LABORATORIES LIMITED
RX8143
In Commercial Distribution

  • 05055273214994 ()
RX8143

  • Wash/cleaning solution IVD, automated/semi-automated system
Aeris Defence is a hospital grade disinfectant.
AERIS ENVIRONMENTAL LTD
LAB-531-02
In Commercial Distribution

  • 09352910002409 ()


  • Medical device disinfection agent
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74140
In Commercial Distribution

  • EBIB741401 ()
74140

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74110
In Commercial Distribution

  • EBIB741101 ()
74110

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74100
In Commercial Distribution

  • EBIB741001 ()
74100

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74090
In Commercial Distribution

  • EBIB740901 ()
74090

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74080
In Commercial Distribution

  • EBIB740801 ()
74080

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74050
In Commercial Distribution

  • EBIB740501 ()
74050

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74040
In Commercial Distribution

  • EBIB740401 ()
74040

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74030
In Commercial Distribution

  • EBIB740301 ()
74030

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74020
In Commercial Distribution

  • EBIB740201 ()
74020

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74010
In Commercial Distribution

  • EBIB740101 ()
74010

  • Dental composite resin
Light curing nanocomposite. Is used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
74000
In Commercial Distribution

  • EBIB740001 ()
74000

  • Dental composite resin
Adson Suction, curved, thumb control is flat
Avalign Technologies, Inc.
VM85-6306
In Commercial Distribution

  • 00190776018528 ()

  • Length: 7.5 Inch
  • Catheter Gauge: 15 French


  • Surgical/emergency suction cannula, non-illuminating, reusable
BPM-656 is a compact blood pressure monitor
Sevenground Trading B.V.
BPM-656
In Commercial Distribution

  • 08719699634497 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
K-MB-716 L is an Adjustable maternity Belt
Sevenground Trading B.V.
K-MB-716 L
In Commercial Distribution

  • 08719699632707 ()


  • Abdominal binder, reusable
WAM800 is a multifunctional eye diagnostic device.
LUNEAU TECHNOLOGY OPERATIONS
WAM 800
In Commercial Distribution

  • 03664188000565 ()


  • Multiple ocular dimension meter
WAM700+ is a multifunctional eye diagnostic device.
LUNEAU TECHNOLOGY OPERATIONS
WAM 700+
In Commercial Distribution

  • 03664188000558 ()


  • Multiple ocular dimension meter
VX90 is an ophthalmic diagnostic device, autorefracto-keratometer
LUNEAU TECHNOLOGY OPERATIONS
VX90
In Commercial Distribution

  • 03664188000169 ()


  • Automated ophthalmic refractometer
One device is included 100 test strips
DFI CO.,LTD
30D4
Not in Commercial Distribution

  • 08806141303497 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
The Multiple Name for PORT-XII is ZEN-PX2.
GENORAY CO., LTD.
PORT-XII
In Commercial Distribution

  • 08809244061035 ()


  • Portable basic diagnostic x-ray system, digital
Camera is intended for surgical/operative procedures.
UNIVLABS TECHNOLOGIES PRIVATE LIMITED
UL3Chip-4K
Not in Commercial Distribution

  • 08908025548083 ()


  • Endoscopic video image processing unit
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