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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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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

Checkpoint - G354CCP042001

Disposable breath alcohol test
Alcopro Inc.
CP04
In Commercial Distribution

  • G354CCP042002 ()
  • G354CCP042001 ()
  • G354CCP042003 ()
  • G354CCP042000 ()
CCP04200

  • Alcohol breath analyser

Checkpoint - G354CCP022001

Disposable breath alcohol test
Alcopro Inc.
CP02
In Commercial Distribution

  • G354CCP022001 ()
  • G354CCP022002 ()
  • G354CCP022003 ()
  • G354CCP022000 ()
CCP02200

  • Alcohol breath analyser

NDL, RBN-132 - M9797405005M0

NDL, RBN-132, STERILE, F/G
RANFAC CORP.
13 GAUGE x 2"
In Commercial Distribution

  • M9797405005M9 ()
  • M9797405005M1 ()
  • M9797405005M0 ()

  • Needle Gauge: 13 Gauge
  • Length: 2 Inch
RBN-132

  • Bone marrow biopsy needle, single-use

NDL, RBN-114, STERILE, F/G - M9797405001M0

NDL, RBN-114, STERILE, F/G PN 74050-01M
RANFAC CORP.
11 GAUGE x 4"
In Commercial Distribution

  • M9797405001M9 ()
  • M9797405001M1 ()
  • M9797405001M0 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114

  • Bone marrow biopsy needle, single-use

ORC-A, F/G ASSY, RANFAC, 18 GA - M9796808401M0

ORC-A, F/G ASSY, RANFAC, 18 GA PN 68084-01M
RANFAC CORP.
18 GAUGE
In Commercial Distribution

  • M9796808401M9 ()
  • M9796808401M1 ()
  • M9796808401M0 ()

  • Needle Gauge: 18 Gauge
ORC-A-18

  • Rigid endoscopic cannula, single-use

GALACTOGRAPHY INFUSION, 31 GA - M9796800806M0

GALACTOGRAPHY INFUSION, 31 GA GIU-31 PN 68008-06M
RANFAC CORP.
31 GAUGE
In Commercial Distribution

  • M9796800806M9 ()
  • M9796800806M1 ()
  • M9796800806M0 ()

  • Needle Gauge: 31 Gauge
GIU-31

  • Breast ductography cannula

SIALOGRAPHY UNIT ENDPORT, 30GA - M9796800803M0

SIALOGRAPHY UNIT ENDPORT, 30GA 30G-END PN 68008-03M
RANFAC CORP.
30 Gauge
In Commercial Distribution

  • M9796800803M9 ()
  • M9796800803M1 ()
  • M9796800803M0 ()

  • Needle Gauge: 30 Gauge
30G-END

  • Salivary gland catheter
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