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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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ANTI-CD20 (B CELL) - 00810119674203

No Description
BIOGENEX LABORATORIES
MU238A-5UC
In Commercial Distribution

  • 00810119674203 ()

  • Total Volume: 0.5 Milliliter
MU238A-5UC

  • CD20 cell marker IVD, antibody

CHANG Medium B - 00810195240606

CHANG Medium Basal. 90mL bottle.
IRVINE SCIENTIFIC, LLC
C100-90ML
In Commercial Distribution

  • 00810195240606 ()
C100

  • Cell culture medium IVD

Tip Calibrator B - 07540209955259

Tip calibrator B for Navient
ClaroNav Kolahi Inc
950-NE-TC-B
In Commercial Distribution

  • 07540209955259 ()


  • Neurological stereotactic surgery system

Registration probe B - 07540209955211

Registration probe B for Navient
ClaroNav Kolahi Inc
950-NE-RP-B
In Commercial Distribution

  • 07540209955211 ()


  • Neurological stereotactic surgery system

Maxillary Seeker B - 07540209955198

Maxillary Seeker B for Navient
ClaroNav Kolahi Inc
950-NE-MS-B
In Commercial Distribution

  • 07540209955198 ()


  • Neurological stereotactic surgery system

Frontal Seeker B - 07540209955181

Frontal seeker B for Navient
ClaroNav Kolahi Inc
950-NE-FS-B
In Commercial Distribution

  • 07540209955181 ()


  • Neurological stereotactic surgery system

Standard B Solution - 00811403010172

To provide calibration points for the Na, K & Cl electrodes for AVL 982, 983 Analyzers.
Diamond Diagnostics Inc.
AV-BP0442D
In Commercial Distribution

  • 00811403010172 ()


  • Multiple electrolyte IVD, calibrator

Standard B Solution - 00811403015887

To provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer.
Diamond Diagnostics Inc.
ME-5410D
In Commercial Distribution

  • 00811403015887 ()


  • Multiple electrolyte IVD, calibrator

ANTI-CD20 (B CELL) - 00810119670281

No Description
BIOGENEX LABORATORIES
AM238-5M
In Commercial Distribution

  • 00810119670281 ()

  • Total Volume: 6 Milliliter
AM238-5M

  • CD20 cell marker IVD, antibody

Lack B matt - E23908161

No.
Dreve Otoplastik GmbH
0816
In Commercial Distribution

  • E23908161 ()
0816

  • Earmould, custom-made

Lack B matt - E23908141

No.
Dreve Otoplastik GmbH
0814
In Commercial Distribution

  • E23908141 ()
0814

  • Earmould, custom-made

Lack B eco - E23908131

No.
Dreve Otoplastik GmbH
0813
In Commercial Distribution

  • E23908131 ()
0813

  • Earmould, custom-made

Lack B eco - E23908121

No.
Dreve Otoplastik GmbH
0812
In Commercial Distribution

  • E23908121 ()
0812

  • Earmould, custom-made

Lack B eco - E23908111

No.
Dreve Otoplastik GmbH
0811
In Commercial Distribution

  • E23908111 ()
0811

  • Earmould, custom-made

Lack B matt - E23908151

No.
Dreve Otoplastik GmbH
0815
In Commercial Distribution

  • E23908151 ()
0815

  • Earmould, custom-made

Reagent Set B - 07332699000348

Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate, Glycerol and Glutamate mounted in a cassette.
M DIALYSIS INC.
Reagent
In Commercial Distribution

  • 07332699000348 ()
8002164

  • Microdialysis system

Vitrification Kit (B) - 24582231462647

Contains VT601US(ES,VS×2), 4 of cryotopUSs(Blue)and Repro Plate
KITAZATO CORPORATION
VT601US-TOP(B)
In Commercial Distribution

  • 24582231462647 ()
  • 14582231462596 ()


  • IVF medium kit

Anti-A,B (AB03) - 23661562105223

Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) (152D12+9113D10) - This reagent is designed to determine the presence of ABO system blood group antigen A and B on the surface of human red blood cells by manual tube method.
DIAGAST
210522
In Commercial Distribution

  • 23661562105223 ()
  • 13661562105226 ()
210522

  • Anti-AB red blood cell grouping IVD, antibody

RAYDENT C&B - 18800003006042

No Description
Ray Co., Ltd
RCB05P
Not in Commercial Distribution

  • 18800003006042 ()


  • Dental appliance fabrication material, ceramic

RAYDENT C&B - 18800003006035

No Description
Ray Co., Ltd
RCB04P
Not in Commercial Distribution

  • 18800003006035 ()


  • Dental appliance fabrication material, ceramic

RAYDENT C&B - 18800003006028

No Description
Ray Co., Ltd
RCB03P
Not in Commercial Distribution

  • 18800003006028 ()


  • Dental appliance fabrication material, ceramic

RAYDENT C&B - 18800003006011

No Description
Ray Co., Ltd
RCB02P
Not in Commercial Distribution

  • 18800003006011 ()


  • Dental appliance fabrication material, ceramic

RAYDENT C&B - 18800003006004

No Description
Ray Co., Ltd
RCB01P
Not in Commercial Distribution

  • 18800003006004 ()


  • Dental appliance fabrication material, ceramic

Sones™ B - 00763000200152

WVN CATH 990705 10PK 7F 125CM SON B HI-F
MEDTRONIC, INC.
990705
Not in Commercial Distribution

  • 20763000200156 ()
  • 00763000200152 ()

  • Length: 125.0 Centimeter
  • Catheter Gauge: 7.0 French
  • Lumen/Inner Diameter: 1.27 Millimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000200121

WVN CATH 990702 10PK 8F 80CM SONE B W1"
MEDTRONIC, INC.
990702
Not in Commercial Distribution

  • 20763000200125 ()
  • 00763000200121 ()

  • Catheter Gauge: 8.0 French
  • Lumen/Inner Diameter: 1.27 Millimeter
  • Length: 80.0 Centimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199975

WVN CATH 008979 10PK 7F SONES B HIFL 100
MEDTRONIC, INC.
008979
Not in Commercial Distribution

  • 20763000199979 ()
  • 00763000199975 ()

  • Catheter Gauge: 7.0 French
  • Lumen/Inner Diameter: 1.27 Millimeter
  • Length: 100.0 Centimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199968

WVN CATH 008978 10PK 7F SONES B HIFL 80
MEDTRONIC, INC.
008978
Not in Commercial Distribution

  • 20763000199962 ()
  • 00763000199968 ()

  • Length: 80.0 Centimeter
  • Catheter Gauge: 7.0 French
  • Lumen/Inner Diameter: 1.27 Millimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199920

WVN CATH 008973 10PK SONES 8F HI FLOW
MEDTRONIC, INC.
008973
Not in Commercial Distribution

  • 20763000199924 ()
  • 00763000199920 ()

  • Lumen/Inner Diameter: 1.473 Millimeter
  • Length: 100.0 Centimeter
  • Catheter Gauge: 8.0 French


  • Angiographic catheter, single-use

Sones™ B - 00763000199869

WVN CATH 008719 10PK 8F SONES B HIFLO 80
MEDTRONIC, INC.
008719
Not in Commercial Distribution

  • 20763000199863 ()
  • 00763000199869 ()

  • Length: 80.0 Centimeter
  • Lumen/Inner Diameter: 1.473 Millimeter
  • Catheter Gauge: 8.0 French


  • Angiographic catheter, single-use

Sones™ B - 00763000199845

CATHETER 008554 WVN 7.5F SONES B 100CM
MEDTRONIC, INC.
008554
Not in Commercial Distribution

  • 20763000199849 ()
  • 00763000199845 ()

  • Length: 100.0 Centimeter
  • Catheter Gauge: 7.5 French
  • Lumen/Inner Diameter: 1.245 Millimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199838

CATHETER 008553 WVN 7.5F SONES B 80CM
MEDTRONIC, INC.
008553
Not in Commercial Distribution

  • 20763000199832 ()
  • 00763000199838 ()

  • Lumen/Inner Diameter: 1.245 Millimeter
  • Length: 80.0 Centimeter
  • Catheter Gauge: 7.5 French


  • Angiographic catheter, single-use

Sones™ B - 00763000199685

CATHETER 007763 WVN 5336 7.5 100POS XSTF
MEDTRONIC, INC.
007763
Not in Commercial Distribution

  • 20763000199689 ()
  • 00763000199685 ()

  • Length: 100.0 Centimeter
  • Catheter Gauge: 7.5 French
  • Lumen/Inner Diameter: 1.245 Millimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199678

CATHETER 007762 WVN 7.5F 80 POS XSTIFF
MEDTRONIC, INC.
007762
Not in Commercial Distribution

  • 20763000199672 ()
  • 00763000199678 ()

  • Lumen/Inner Diameter: 1.245 Millimeter
  • Catheter Gauge: 7.5 French
  • Length: 80.0 Centimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199661

WVN CATH 007562 10PK 5330S 7.5 100SNESPT
MEDTRONIC, INC.
007562
Not in Commercial Distribution

  • 20763000199665 ()
  • 00763000199661 ()

  • Length: 100.0 Centimeter
  • Catheter Gauge: 7.5 French
  • Lumen/Inner Diameter: 1.245 Millimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199654

WVN CATH 007561 10PK 5330S 7.5 80 SNESPT
MEDTRONIC, INC.
007561
Not in Commercial Distribution

  • 20763000199658 ()
  • 00763000199654 ()

  • Lumen/Inner Diameter: 1.245 Millimeter
  • Length: 80.0 Centimeter
  • Catheter Gauge: 7.5 French


  • Angiographic catheter, single-use

Sones™ B - 00763000199647

WVN CATH 007551 10PK 5423S 8 100 SONESCR
MEDTRONIC, INC.
007551
Not in Commercial Distribution

  • 20763000199641 ()
  • 00763000199647 ()

  • Lumen/Inner Diameter: 1.27 Millimeter
  • Catheter Gauge: 8.0 French
  • Length: 100.0 Centimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199630

WVN CATH 007550 10PK 5423S 8 80 SONESCR
MEDTRONIC, INC.
007550
Not in Commercial Distribution

  • 20763000199634 ()
  • 00763000199630 ()

  • Catheter Gauge: 8.0 French
  • Length: 80.0 Centimeter
  • Lumen/Inner Diameter: 1.27 Millimeter


  • Angiographic catheter, single-use

Sones™ B - 00763000199623

WVN CATH 007548 10PK 5423S 7 100 SONESCR
MEDTRONIC, INC.
007548
Not in Commercial Distribution

  • 20763000199627 ()
  • 00763000199623 ()

  • Lumen/Inner Diameter: 1.245 Millimeter
  • Catheter Gauge: 7.0 French
  • Length: 100.0 Centimeter


  • Angiographic catheter, single-use

TruTemp C&B - D724N1101181

C2
PEARSON DENTAL SUPPLIES, INC.
N110118
In Commercial Distribution

  • D724N1101181 ()


  • Temporary dental crown/bridge resin

TruTemp C&B - D724N1101161

A3
PEARSON DENTAL SUPPLIES, INC.
N110116
In Commercial Distribution

  • D724N1101161 ()


  • Temporary dental crown/bridge resin
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