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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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Trulife - 00645517578347

LF2 W/PYR 24 L 3/8 145-184# DKBRN
TRULIFE LIMITED
SLF198-24-L-H7
In Commercial Distribution

  • 00645517578347 ()


  • Mechanical-resistance external ankle-foot prosthesis

Trulife - 00645517578330

LF2 W/PYR 24 L 3/8 114-144# DKBRN
TRULIFE LIMITED
SLF198-24-L-H6
In Commercial Distribution

  • 00645517578330 ()


  • Mechanical-resistance external ankle-foot prosthesis

Trulife - 00645517578323

LF2 W/PYR 24 L 3/8 90-113# DKBRN
TRULIFE LIMITED
SLF198-24-L-H5
In Commercial Distribution

  • 00645517578323 ()


  • Mechanical-resistance external ankle-foot prosthesis

G-Rex - 00850019717006

G-Rex 24 Well Cell Culture Plate, Research Use Only
WILSON WOLF MANUFACTURING CORPORATION
80192M
In Commercial Distribution

  • 00850019717006 ()
80192M

  • Blood/tissue storage/culture container

Sterimed - 00850341007950

Equipment Drape (Foot switch) 24" X 19" (A0307) Non-Sterile
STERIMED LLC
A0307
In Commercial Distribution

  • 10850341007957 ()
  • 00850341007950 ()


  • X-ray system cover

GAESCA - 00850051333288

Wheelchair for overweight people - removable foot rest 24" width
Mp2g Diagnostic Corp
Gaesca Wheelchair for overweight people - removable foot rest 24" width
In Commercial Distribution

  • 00850051333288 ()


  • Push-rim manual wheelchair, bariatric

SurgiLock - 00850047863218

Foam Pad 24" x 6" x 1" w/ Elastak
Medicalock Corporation
24" x 6" Pad
In Commercial Distribution

  • 00850047863218 ()
SLFPE2406

  • Freestanding patient positioner, single-use

SurgiLock - 00850047863195

Torso Pad 20" x 24" x 1" w/ Elastak
Medicalock Corporation
20" x 24" Torso Pad
In Commercial Distribution

  • 00850047863195 ()
SLFPE2024

  • Freestanding patient positioner, single-use

ComfyComboPlus - 00850209007061

DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS
MEDICAL FINANCE RESOURCES INC
COMFYCOMBOPLUS-EVMFR
In Commercial Distribution

  • 10850209007075 ()
  • 00850209007078 ()
  • 00850209007061 ()
COMFYCOMBOPLUS-EVMFR

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

American Hospital Supply - 00850046814600

AHS Foam Positioner | Multi Ring Cushion | Case of 24
American Hospital Supply LLC
AHS-FP-MRC_CS
In Commercial Distribution

  • 00850046814877 ()
  • 00850046814600 ()
AHS-FP-MRC_CS

  • Freestanding patient positioner, single-use

Spectrum, Inc. - 00850301007648

Equipment Drape, FT Switch Cover, 14" X 24", Non-sterile
SPECTRUM, INC.
982-03762-000
In Commercial Distribution

  • 10850301007645 ()
  • 00850301007648 ()
701424NS

  • Instrument/equipment drape, single-use, non-sterile

3M™ Unitek™ - 00652221039408

Unitek(TM) Bicuspid Band Proportional L4,5 Size 24 Ea
3M UNITEK CORPORATION
149-224
In Commercial Distribution

  • 00652221039408 ()
  • 80652221039404 ()
149-224

  • Orthodontic metal band

3M™ Unitek™ - 00652221039101

Unitek(TM) Bicuspid Band Proportional U4,5 Size 24 Ea
3M UNITEK CORPORATION
149-124
In Commercial Distribution

  • 00652221039101 ()
  • 80652221039107 ()
149-124

  • Orthodontic metal band

Starboard Temperature Probes - 00850933007054

Esophageal Stethoscope with 400 Series Temperature Sensor, 24 Fr.
STARBOARD MEDICAL, INC.
40024-ES
In Commercial Distribution

  • 10850933007051 ()
  • 00850933007054 ()
40024-ES

  • Electronic oesophageal stethoscope, single-use

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24 - 00858736006069

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-5710
In Commercial Distribution

  • 00858736006069 ()
  • 00858736006175 ()
7013-5710

  • Haemostatic knife

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24 - 00858736006045

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-5715
In Commercial Distribution

  • 00858736006045 ()
  • 00858736006137 ()
7013-5715

  • Haemostatic knife

eSensor® XT-8 - 00857167005276

eSensor® Warfarin Sensitivity Test Reagent Pack (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005276 ()
MT002001

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

eSensor® XT-8 - 00857167005252

eSensor® Warfarin Sensitivity Test Detection Reagents (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005252 ()
MT002001

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

NTERFACE - 00858150000490

Large Sheet 12 inches X 24 inches - Box 12
WINFIELD LABORATORIES INC
3810-288
In Commercial Distribution

  • 00858150000520 ()
  • 00858150000490 ()
  • 10858150000497 ()
3810-288

  • Wound-nonadherent dressing, absorbent, non-antimicrobial

A Plus - 00683534080481

Back table cover 70"x110;3mil,24/bag,384/glrd
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080487 ()
  • 00683534080481 ()
BT70110-1F

  • Medical equipment/instrument drape, single-use

Biotronix Healthcare Cotton Cast Padding - 00858835007868

Cotton Cast Padding, 2" x 4.1yds, 24 Rolls/Bag
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
PO2001
In Commercial Distribution

  • 10858835007865 ()
  • 00858835007868 ()

  • Cotton Cast Padding, 2" x 4.1yds, 24 Rolls/Bag
PO2001

  • General-purpose medical fibre padding

Medegen Medical Products - 00700812001218

Urinal w/Comfort Ring Att 50/cs 24/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H140CR-01
In Commercial Distribution

  • 10700812001215 ()
  • 00700812001218 ()
H140CR-01

  • Hand-held urinal, single-use

dentaform® - J011885324220

dentaform® Band, tooth 36, size 24/Roth 22
DENTAURUM GmbH & Co.KG
885-324-22
In Commercial Distribution

  • J011885324220 ()


  • Orthodontic metal band

dentaform® - J011884324220

dentaform® Band, tooth 46, size 24/Roth 22
DENTAURUM GmbH & Co.KG
884-324-22
In Commercial Distribution

  • J011884324220 ()


  • Orthodontic metal band

dentaform® - J011884024220

dentaform® Band, Tooth 46, Size 24/Roth 22
DENTAURUM GmbH & Co.KG
884-024-22
Not in Commercial Distribution

  • J011884024220 ()


  • Orthodontic metal band

dentaform® - J011884024180

dentaform® Band, Tooth 46, Size 24/Roth 18
DENTAURUM GmbH & Co.KG
884-024-18
Not in Commercial Distribution

  • J011884024180 ()


  • Orthodontic metal band

dentaform® - J011885024220

dentaform® Band, Tooth 36, Size 24/Roth 22
DENTAURUM GmbH & Co.KG
885-024-22
Not in Commercial Distribution

  • J011885024220 ()


  • Orthodontic metal band

dentaform® - J011885024180

dentaform® Band, Tooth 36, Size 24/Roth 18
DENTAURUM GmbH & Co.KG
885-024-18
Not in Commercial Distribution

  • J011885024180 ()


  • Orthodontic metal band

dentaform® - J011883324220

dentaform® Band, tooth 26, size 24/Roth 22
DENTAURUM GmbH & Co.KG
883-324-22
In Commercial Distribution

  • J011883324220 ()


  • Orthodontic metal band

dentaform® - J011883324180

dentaform® Band, tooth 26, size 24/Roth 18
DENTAURUM GmbH & Co.KG
883-324-18
In Commercial Distribution

  • J011883324180 ()


  • Orthodontic metal band

dentaform® - J011883024220

dentaform® Band, Tooth 26, Size 24/Roth 22
DENTAURUM GmbH & Co.KG
883-024-22
Not in Commercial Distribution

  • J011883024220 ()


  • Orthodontic metal band

dentaform® - J011883024180

dentaform® Band, Tooth 26, Size 24/Roth 18
DENTAURUM GmbH & Co.KG
883-024-18
Not in Commercial Distribution

  • J011883024180 ()


  • Orthodontic metal band

dentaform® - J011880324220

dentaform® Snap, tooth 46,size 24/Roth 22
DENTAURUM GmbH & Co.KG
880-324-22
In Commercial Distribution

  • J011880324220 ()


  • Orthodontic metal band

dentaform® - J011880324180

dentaform® Snap, tooth 46, size 24/Roth 18
DENTAURUM GmbH & Co.KG
880-324-18
In Commercial Distribution

  • J011880324180 ()


  • Orthodontic metal band

dentaform® - J011882324220

dentaform® Band, tooth 16, size 24/Roth 22
DENTAURUM GmbH & Co.KG
882-324-22
In Commercial Distribution

  • J011882324220 ()


  • Orthodontic metal band

dentaform® - J011882324180

dentaform® Band, tooth 16, size 24/Roth 18
DENTAURUM GmbH & Co.KG
882-324-18
In Commercial Distribution

  • J011882324180 ()


  • Orthodontic metal band

dentaform® - J011882024220

dentaform® Band, Tooth 16, Size 24/Roth 22
DENTAURUM GmbH & Co.KG
882-024-22
Not in Commercial Distribution

  • J011882024220 ()


  • Orthodontic metal band

dentaform® - J011882024180

dentaform® Band, Tooth 16, Size 24/Roth 18
DENTAURUM GmbH & Co.KG
882-024-18
Not in Commercial Distribution

  • J011882024180 ()


  • Orthodontic metal band

dentaform® - J011881324220

dentaform® Snap, tooth 36, size 24/Roth 22
DENTAURUM GmbH & Co.KG
881-324-22
In Commercial Distribution

  • J011881324220 ()


  • Orthodontic metal band

Paul Banditt - D955BCUM241

PAUL BANDITT MOLT 2-4 BONE CURETTE, DE, #4 HANDLE
Terlain Enterprises, Inc.
BCUM24
In Commercial Distribution

  • D955BCUM241 ()


  • Bone curette, reusable
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