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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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Skintx - B75450000

Nitrile Powder Free Examination Size Extra Small
GD CARE INC.
50000
In Commercial Distribution

  • B754500001 ()
  • B75450000 ()
  • B754500002 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

UltraFlo Insulin Pen Needle - B7443357761

33G x 5/32" (4mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335776
In Commercial Distribution

  • B7443357763 ()
  • B7443357762 ()
  • B7443357761 ()
  • B7443357760 ()


  • Autoinjector needle

UltraFlo Insulin Pen Needle - B7443357741

32G X 5/32" (4mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335774
In Commercial Distribution

  • B7443357743 ()
  • B7443357742 ()
  • B7443357741 ()
  • B7443357740 ()


  • Autoinjector needle

UltraFlo Insulin Pen Needle - B7443357731

31G X 5/16" (8mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335773
In Commercial Distribution

  • B7443357733 ()
  • B7443357732 ()
  • B7443357731 ()
  • B7443357730 ()


  • Autoinjector needle

UltraFlo Insulin Pen Needle - B7443357721

31G X 3/16" (5mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335772
In Commercial Distribution

  • B7443357723 ()
  • B7443357722 ()
  • B7443357721 ()
  • B7443357720 ()


  • Autoinjector needle

UltraFlo Insulin Pen Needle - B7443357711

29G X 1/2" (12mm)
QUALITY MEDICAL PRODUCTS USA, INC.
335771
In Commercial Distribution

  • B7443357713 ()
  • B7443357712 ()
  • B7443357711 ()
  • B7443357710 ()


  • Autoinjector needle

UltraFlo Insulin Syringe - B7442259451

0.3ML 31GX5/16" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225945
In Commercial Distribution

  • B7442259453 ()
  • B7442259452 ()
  • B7442259451 ()
  • B7442259450 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259441

1 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225944
In Commercial Distribution

  • B7442259443 ()
  • B7442259442 ()
  • B7442259441 ()
  • B7442259440 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259431

1 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225943
In Commercial Distribution

  • B7442259433 ()
  • B7442259432 ()
  • B7442259431 ()
  • B7442259430 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259421

1 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225942
In Commercial Distribution

  • B7442259423 ()
  • B7442259422 ()
  • B7442259421 ()
  • B7442259420 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259411

1 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225941
In Commercial Distribution

  • B7442259413 ()
  • B7442259412 ()
  • B7442259411 ()
  • B7442259410 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259401

0.5 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225940
In Commercial Distribution

  • B7442259403 ()
  • B7442259402 ()
  • B7442259401 ()
  • B7442259400 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259391

0.5 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225939
In Commercial Distribution

  • B7442259393 ()
  • B7442259392 ()
  • B7442259391 ()
  • B7442259390 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259381

0.5 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225938
In Commercial Distribution

  • B7442259383 ()
  • B7442259382 ()
  • B7442259381 ()
  • B7442259380 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259371

0.5 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225937
In Commercial Distribution

  • B7442259373 ()
  • B7442259372 ()
  • B7442259371 ()
  • B7442259370 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259361

0.3 ML 31GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225936
In Commercial Distribution

  • B7442259363 ()
  • B7442259362 ()
  • B7442259361 ()
  • B7442259360 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259351

0.3 ML 30GX5/16" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225935
In Commercial Distribution

  • B7442259353 ()
  • B7442259352 ()
  • B7442259351 ()
  • B7442259350 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259341

0.3 ML 30GX5/16"
QUALITY MEDICAL PRODUCTS USA, INC.
225934
In Commercial Distribution

  • B7442259343 ()
  • B7442259342 ()
  • B7442259341 ()
  • B7442259340 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259331

0.3 ML 30GX1/2" 1/2 UNIT MARKING
QUALITY MEDICAL PRODUCTS USA, INC.
225933
In Commercial Distribution

  • B7442259333 ()
  • B7442259332 ()
  • B7442259331 ()
  • B7442259330 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259321

0.3 ML 30GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225932
In Commercial Distribution

  • B7442259323 ()
  • B7442259322 ()
  • B7442259321 ()
  • B7442259320 ()


  • Insulin syringe/needle, basic

UltraFlo Insulin Syringe - B7442259311

0.3 ML 29GX1/2"
QUALITY MEDICAL PRODUCTS USA, INC.
225931
In Commercial Distribution

  • B7442259313 ()
  • B7442259312 ()
  • B7442259311 ()
  • B7442259310 ()


  • Insulin syringe/needle, basic

BodyTrace - B726BT1060

Upper arm blood pressure monitor.
BODYTRACE, INC
BT106
In Commercial Distribution

  • B726BT1061 ()
  • B726BT1060 ()
  • B726BT1062 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Omada - B726BT105O0

Upper arm blood pressure monitor.
BODYTRACE, INC
BT105O
In Commercial Distribution

  • B726BT105O1 ()
  • B726BT105O0 ()
  • B726BT105O2 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BodyTrace - B726BT1050

Upper arm blood pressure monitor.
BODYTRACE, INC
BT105
In Commercial Distribution

  • B726BT1051 ()
  • B726BT1050 ()
  • B726BT1052 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Omada - B726BT104O0

Upper arm blood pressure monitor.
BODYTRACE, INC
BT104O
In Commercial Distribution

  • B726BT104O2 ()
  • B726BT104O1 ()
  • B726BT104O0 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BodyTrace - B726BT1040

Upper arm blood pressure monitor.
BODYTRACE, INC
BT104
In Commercial Distribution

  • B726BT1042 ()
  • B726BT1041 ()
  • B726BT1040 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BodyTrace - B726BT007B0

Weight scale.
BODYTRACE, INC
BT007B
In Commercial Distribution

  • B726BT007B1 ()
  • B726BT007B0 ()
  • B726BT007B2 ()


  • Stand-on floor scale, electronic

BodyTrace - B726BT007A0

Weight scale.
BODYTRACE, INC
BT007A
In Commercial Distribution

  • B726BT007A1 ()
  • B726BT007A0 ()
  • B726BT007A2 ()


  • Stand-on floor scale, electronic

BodyTrace - B726BT0060

Weight scale.
BODYTRACE, INC
BT006
In Commercial Distribution

  • B726BT0061 ()
  • B726BT0060 ()
  • B726BT0062 ()


  • Stand-on floor scale, electronic

Vida - B726BT005V0

Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT005V1 ()
  • B726BT005V0 ()
  • B726BT005V2 ()


  • Stand-on floor scale, electronic

Omada - B726BT005O0

Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT005O1 ()
  • B726BT005O0 ()
  • B726BT005O2 ()


  • Stand-on floor scale, electronic

BodyTrace - B726BT0050

Weight scale.
BODYTRACE, INC
BT005
In Commercial Distribution

  • B726BT0051 ()
  • B726BT0050 ()
  • B726BT0052 ()


  • Stand-on floor scale, electronic

Shukla Blade S9BLADE - B756SBLDFLAT1SP0

BLADE, FLAT, 8MM X 5CM, SINGLE USE, STERILE PACKED
Shukla Medical
SBLDFLAT-1-SP
In Commercial Distribution

  • B756SBLDFLAT1SP1 ()
  • B756SBLDFLAT1SP0 ()
  • B756SBLDFLAT1SP5 ()


  • Orthopaedic osteotome blade, single-use

Soviflex - B79510010

Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor

SPEAX Patch - B792FGN002

Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system

XCELL - B708XCPSPC1200

XCELL PC Fluid Volume Reducer 120ml XC-PSPC-120
APEX BIOLOGIX , LLC
XC-PSPC-120
In Commercial Distribution

  • B708XCPSPC1201 ()
  • B708XCPSPC1200 ()
  • B708XCPSPC1202 ()


  • Haematological concentrate system preparation kit, platelet concentration

ACETONE BLANK - B800ACEBLKSFBSRHS0

ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control

OLO CBC Test Kit - B787TK10

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
Not in Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count

FlexStone Basket - G380FSA120210

Single-Use Steerable Basket
EndoTheia, Inc.
FSA-120-21
In Commercial Distribution

  • G380FSA120210 ()
  • G380FSA120211 ()
  • G380FSA120212 ()


  • Urinary stone retrieval basket, single-use

Checkpoint - G354CCP082001

Disposable breath alcohol test
Alcopro Inc.
CP08
In Commercial Distribution

  • G354CCP082002 ()
  • G354CCP082001 ()
  • G354CCP082003 ()
  • G354CCP082000 ()
CCP08200

  • Alcohol breath analyser
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