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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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RAYDENT C&B - 18800003006004

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

  • 18800003006004 ()


  • Dental appliance fabrication material, ceramic

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

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

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

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

TruTemp C&B - D724N1101141

A2
PEARSON DENTAL SUPPLIES, INC.
N110114
In Commercial Distribution

  • D724N1101141 ()


  • Temporary dental crown/bridge resin

TruTemp C&B - D724N1101121

A1
PEARSON DENTAL SUPPLIES, INC.
N110112
In Commercial Distribution

  • D724N1101121 ()


  • Temporary dental crown/bridge resin

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

B/IS-15 SS2 - 00885672102722

No Description
Oscor Inc.
B/IS-15 SS2
In Commercial Distribution

  • 00885672102722 ()
B/IS-15 SS2

  • Pacing/defibrillation lead electrical adaptor

BD Trucount - 00382903403349

BD Trucount™ Tubes
Becton, Dickinson And Company
340334
In Commercial Distribution

  • 00382903403349 ()
  • 80382903403345 ()
340334

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
  • White blood cell count IVD, reagent

Acucy Calibration Device - 00742860100345

No Description
SEKISUI DIAGNOSTICS, LLC
1031
Not in Commercial Distribution

  • 00742860100345 ()


  • Optical laboratory instrument performance standard calibrator/control IVD, reusable

Acucy System - 00742860100338

No Description
SEKISUI DIAGNOSTICS, LLC
1039
Not in Commercial Distribution

  • 00742860100338 ()


  • Photometric/spectroscopic immunoassay analyser IVD

OSOM Ultra Flu Aspirate 25T Kit - 00742860100239

OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC
1007
In Commercial Distribution

  • 00742860100239 ()
  • 10742860100236 ()
1007

  • Nasopharyngeal aspirate container IVD

BD Veritor™ System CLIA-Waived Combo Pack - 00382902560715

BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)
BECTON, DICKINSON AND COMPANY
256071
Not in Commercial Distribution

  • 00382902560715 ()
256071

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical

Silaris Dock - B54010260

The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

SCISSORS OPERATING 6" CRV. B/B TC - D9283001060

No Description
W.H. Holden, Inc.
30-0106
In Commercial Distribution

  • D9283001060 ()


  • Dental surgical scissors

SCISSORS OPERATING 6" STR B/B TC - D9283001030

No Description
W.H. Holden, Inc.
30-0103
In Commercial Distribution

  • D9283001030 ()


  • Dental surgical scissors

CARDINAL HEALTH - 10195594304881

OPEN HEART BASIC B PACK
Cardinal Health 200, LLC
SCV42BBML7
In Commercial Distribution

  • 50195594304889 ()
  • 10195594304881 ()
SCV42BBML7

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594304232

OPEN HEART B PACK GSAM
Cardinal Health 200, LLC
SCVCGOBSG6
In Commercial Distribution

  • 50195594304230 ()
  • 10195594304232 ()
SCVCGOBSG6

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10195594298333

HEART PACK A AND B
Cardinal Health 200, LLC
SCV55OP694
In Commercial Distribution

  • 50195594298331 ()
  • 10195594298333 ()
SCV55OP694

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10195594172305

B V CHOL BY LAPAROSCOPY
Cardinal Health 200, LLC
SLC30CLPR6
In Commercial Distribution

  • 50195594172303 ()
  • 10195594172305 ()
SLC30CLPR6

  • Laparoscopic surgical procedure kit, medicated

CARDINAL HEALTH - 10195594171230

CV A AND B PACK
Cardinal Health 200, LLC
SCV37CVJ10
In Commercial Distribution

  • 50195594171238 ()
  • 10195594171230 ()
SCV37CVJ10

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10195594208363

KIT,OPEN HEART A B
Cardinal Health 200, LLC
PVDHOH673
In Commercial Distribution

  • 50195594208361 ()
  • 10195594208363 ()
PVDHOH673

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10195594206024

OPEN HEART BASIC B PACK
Cardinal Health 200, LLC
SCV42BBML6
In Commercial Distribution

  • 50195594206022 ()
  • 10195594206024 ()
SCV42BBML6

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594201685

KIT, TOTAL HIP B E159301
Cardinal Health 200, LLC
POMVTBNM3
In Commercial Distribution

  • 50195594201683 ()
  • 10195594201685 ()
POMVTBNM3

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594198572

OPEN HEART PACK B ILM
Cardinal Health 200, LLC
SCVCGOHIL2
In Commercial Distribution

  • 50195594198570 ()
  • 10195594198572 ()
SCVCGOHIL2

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594196141

OPEN HEART B PACK GSAM
Cardinal Health 200, LLC
SCVCGOBSG5
In Commercial Distribution

  • 50195594196149 ()
  • 10195594196141 ()
SCVCGOBSG5

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10195594191276

FREE FLAP CUSTOM PACK B
Cardinal Health 200, LLC
SOP56FBUU5
In Commercial Distribution

  • 50195594191274 ()
  • 10195594191276 ()
SOP56FBUU5

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594186517

ONHS FREE FLAP B PACK
Cardinal Health 200, LLC
SBA51FBUS1
In Commercial Distribution

  • 50195594186515 ()
  • 10195594186517 ()
SBA51FBUS1

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594238377

B V CHOL BY LAPAROSCOPY
Cardinal Health 200, LLC
SLC30CLPR7
In Commercial Distribution

  • 50195594238375 ()
  • 10195594238377 ()
SLC30CLPR7

  • Laparoscopic surgical procedure kit, medicated

CARDINAL HEALTH - 10195594235222

OPEN HEART PACK A B
Cardinal Health 200, LLC
SCVOCOHVH9
In Commercial Distribution

  • 50195594235220 ()
  • 10195594235222 ()
SCVOCOHVH9

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
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