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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Orthopedic Goniometer
GF HEALTH PRODUCTS, INC.
12-1001
In Commercial Distribution

  • M3681210012 ()
  • M3681210011 ()


  • Manual goniometer
Orthopedic Goniometer
GF HEALTH PRODUCTS, INC.
12-1000
In Commercial Distribution

  • M36812100002 ()
  • M3681210001 ()


  • Manual goniometer
Deluxe Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-510LA
In Commercial Distribution

  • M368100510LA1 ()
  • M368100510LA2 ()


  • Aneroid manual sphygmomanometer
Deluxe Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-510
In Commercial Distribution

  • M3681005101 ()
  • M3681005102 ()


  • Aneroid manual sphygmomanometer
Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-040P
In Commercial Distribution

  • M368100040P1 ()
  • M368100040P2 ()


  • Aneroid manual sphygmomanometer
Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-040ORC
In Commercial Distribution

  • M368100040ORC1 ()
  • M368100040ORC2 ()


  • Aneroid manual sphygmomanometer
Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-040HG
In Commercial Distribution

  • M368100040HG1 ()
  • M368100040HG2 ()


  • Aneroid manual sphygmomanometer
Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-040GRP
In Commercial Distribution

  • M368100040GRP1 ()
  • M368100040GRP2 ()


  • Aneroid manual sphygmomanometer
Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-040DB
In Commercial Distribution

  • M368100040DB1 ()
  • M368100040DB2 ()


  • Aneroid manual sphygmomanometer
Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-040BUR
In Commercial Distribution

  • M368100040BUR1 ()
  • M368100040BUR2 ()


  • Aneroid manual sphygmomanometer
Aneroid Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
100-040BK
In Commercial Distribution

  • M368100040BK1 ()
  • M368100040BK2 ()


  • Aneroid manual sphygmomanometer
Professional Aneroid Sphygmomanometer Thigh
GF HEALTH PRODUCTS, INC.
100-001TH
In Commercial Distribution

  • M368100001TH2 ()
  • M368100001TH1 ()


  • Aneroid manual sphygmomanometer
Professional Aneroid Sphygmomanometer Child
GF HEALTH PRODUCTS, INC.
100-001NCHI
In Commercial Distribution

  • M368100001NCHI2 ()
  • M368100001NCHI1 ()


  • Aneroid manual sphygmomanometer
Aneroid Sphygmomanometer
GF HEALTH PRODUCTS, INC.
100-001N
In Commercial Distribution

  • M368100001N1 ()
  • M368100001N2 ()


  • Aneroid manual sphygmomanometer
Professional Aneroid Sphygmomanometer Large
GF HEALTH PRODUCTS, INC.
100-001LA
In Commercial Distribution

  • M36810001LA2 ()
  • M368100001LA1 ()


  • Aneroid manual sphygmomanometer
Professional Aneroid Sphygmomanometer Infant
GF HEALTH PRODUCTS, INC.
100-001INF
In Commercial Distribution

  • M368100001INF2 ()
  • M368100001INF1 ()


  • Aneroid manual sphygmomanometer
Professional Aneroid Sphygmomanometer Child
GF HEALTH PRODUCTS, INC.
100-001CHI
In Commercial Distribution

  • M368100001CHI1 ()
  • M368100001CHI2 ()


  • Aneroid manual sphygmomanometer
Aneroid Sphygmomanometer
GF HEALTH PRODUCTS, INC.
100-001
In Commercial Distribution

  • M3681000011 ()
  • M3681000012 ()


  • Aneroid manual sphygmomanometer
Raised Toliet Seat Cushion
GF HEALTH PRODUCTS, INC.
6484R-2
In Commercial Distribution

  • M3686484R22 ()
  • M3686484R21 ()
6484R-2

  • Toilet cushion
Lumineb II Nebulizer Compressor
GF HEALTH PRODUCTS, INC.
5710
In Commercial Distribution

  • M36857102 ()
  • M36857101 ()


  • Benchtop nebulizer, non-heated
72" Gait Belt
GF HEALTH PRODUCTS, INC.
5597R-72-1
In Commercial Distribution

  • M3685597R7212 ()
  • M3685597R7211 ()
5597R-72-1

  • Wheelchair/chair/stander occupant restraint/support
54" Gait Belt
GF HEALTH PRODUCTS, INC.
5597R-54-1
In Commercial Distribution

  • M3685597R5412 ()
  • M3685597R5411 ()
5597R-54-1

  • Wheelchair/chair/stander occupant restraint/support
A modified Cary and Blair Medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen. The tubes are supplied with red caps and a spork for specimen handling.
MEDICAL CHEMICAL CORPORATION
2805-05_RED_SP
In Commercial Distribution

  • M445280505REDSP02 ()
  • M445280505REDSP1 ()
  • M445280505REDSP0 ()
2805-05_RED_SP

  • Carey-Blair transport medium IVD
A modified Cary and Blair Medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.
MEDICAL CHEMICAL CORPORATION
2805-05_ORANGE
In Commercial Distribution

  • M445280505ORNG2 ()
  • M445280505ORNG1 ()
  • M445280505ORNG0 ()
2805-05_ORANGE

  • Carey-Blair transport medium IVD
The Wavicide MEC Indicator is a semi-quantitative indicator designed to monitor the glutaraldehyde concentration of Wavicide-01.
MEDICAL CHEMICAL CORPORATION
0306-Strips
In Commercial Distribution

  • M44503060 ()
  • M44503061 ()
0306-Strips

  • Glutaraldehyde device disinfectant/sterilant test strip
Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.
MEDICAL CHEMICAL CORPORATION
0112-32oz
In Commercial Distribution

  • M445011232OZ1 ()
  • M445011232OZ0 ()
0112-32oz

  • Glutaraldehyde device sterilant
Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.
MEDICAL CHEMICAL CORPORATION
0104-1gl IRI
In Commercial Distribution

  • M44501041GLIRI1 ()
  • M44501041GLIRI0 ()
0104-1gl IRI

  • Glutaraldehyde device sterilant
Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.
MEDICAL CHEMICAL CORPORATION
0104-1gl
In Commercial Distribution

  • M44501041GL1 ()
  • M44501041GL0 ()
0104-1gl

  • Glutaraldehyde device sterilant
Self-Drilling Screw - Ø1.9 mm x 4 mm (6) [10 PK]
Bioplate, Inc.
81-3585
In Commercial Distribution

  • M3848135851 ()
  • M3848135850 ()
81-3585

  • Craniofacial bone screw, non-bioabsorbable
Compression Plate - Ø1.9 mm - 2 hole - 15 mm (1), Self-Drilling Screw - 4 mm (2) [5 PK]
Bioplate, Inc.
81-3583
In Commercial Distribution

  • M3848135831 ()
  • M3848135830 ()
81-3583

  • Neurosurgical procedure kit, non-medicated, single-use
Zip® Implant - 20 mm (STERILE) [6 PK]
Bioplate, Inc.
81-3518
Not in Commercial Distribution

  • M3848135181 ()
  • M3848135180 ()
81-3518

  • Cranioplasty plate, non-alterable
Zip® Implant - 16 mm (STERILE) [6 PK]
Bioplate, Inc.
81-3517
Not in Commercial Distribution

  • M3848135171 ()
  • M3848135170 ()
81-3517

  • Cranioplasty plate, non-alterable
Zip® Implant - 12 mm (STERILE) [6 PK]
Bioplate, Inc.
81-3516
Not in Commercial Distribution

  • M3848135161 ()
  • M3848135160 ()
81-3516

  • Cranioplasty plate, non-alterable
Self-Drilling Screw - Ø1.9 mm x 4 mm (3) [10 PK]
Bioplate, Inc.
81-2094
In Commercial Distribution

  • M3848120941 ()
  • M3848120940 ()
81-2094

  • Craniofacial bone screw, non-bioabsorbable
UNNA'S Boot Dressing with Calamine
GF HEALTH PRODUCTS, INC.
UNNA-C4
In Commercial Distribution

  • M368UNNAC42 ()
  • M368UNNAC41 ()


  • Adhesive bandage
UNNA'S Boot Dressing with Calamine
GF HEALTH PRODUCTS, INC.
UNNA-C3
In Commercial Distribution

  • M368UNNAC32 ()
  • M368UNNAC31 ()


  • Adhesive bandage
UNNA'S Boot Dressing
GF HEALTH PRODUCTS, INC.
UNNA4
In Commercial Distribution

  • M368UNNA42 ()
  • M368UNNA41 ()


  • Adhesive bandage
UNNA'S Boot Dressing
GF HEALTH PRODUCTS, INC.
UNNA3
In Commercial Distribution

  • M368UNNA32 ()
  • M368UNNA31 ()


  • Adhesive bandage
Standard TENS Unit
GF HEALTH PRODUCTS, INC.
SW-1000
In Commercial Distribution

  • M368SW10002 ()
  • M368SW10001 ()


  • Analgesic transcutaneous electrical nerve stimulation system
Economy TENS Unit
GF HEALTH PRODUCTS, INC.
LUMI-TENS
In Commercial Distribution

  • M368LUMITENS2 ()
  • M368LUMITENS1 ()


  • Analgesic transcutaneous electrical nerve stimulation system
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