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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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Soprano® - 07640173095057

Soprano® Flu-Shade B
Cendres+Métaux SA
08055245
In Commercial Distribution

  • 07640173095057 ()
08055245

  • Dental appliance fabrication material, ceramic

Inocu Swabs - 10634853001272

Group B Strep Negative
MICROBIOLOGICS INC.
GBS-02
In Commercial Distribution

  • 10634853001272 ()
GBS-02

  • PCR/NAT negative control IVD

Inocu Swabs - 10634853001227

VRE Positive (Van B)
MICROBIOLOGICS INC.
CE VRE-03
In Commercial Distribution

  • 10634853001227 ()
CE VRE-03

  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control

CGI - 00817477026347

Stain B Powder 10g
CERAGROUP INDUSTRIES INC.
TSTBS
In Commercial Distribution

  • 00817477026347 ()


  • Dental appliance fabrication material, ceramic

CGI - 00817477025890

Stain B Powder 1000g
CERAGROUP INDUSTRIES INC.
TSTBX
In Commercial Distribution

  • 00817477025890 ()


  • Dental appliance fabrication material, ceramic

CGI - 00817477020130

Stain Paste B 3g
CERAGROUP INDUSTRIES INC.
TSTPB
In Commercial Distribution

  • 00817477020130 ()


  • Dental appliance fabrication material, ceramic

Cup impactor adapter B - 07640176971204

Cup impactor adapter B
Naviswiss AG
NS120
In Commercial Distribution

  • 07640176971204 ()


  • Optical surgical navigation device tracking system

Sklar® - 10649111251931

MEYERDING RETR "B" 7"
SKLAR CORPORATION
22-8211
In Commercial Distribution

  • 10649111251931 ()


  • Hand-held surgical retractor, reusable

PERLA ® TL MIS - 07640305160240

DILATOR TUBE #1 - B
SpineArt SA
MPF-IN 05 01-N
In Commercial Distribution

  • 07640305160240 ()
MPF-IN 05 01-N

  • Orthopaedic implantation sleeve, reusable

JULIET ® INSTRUMENTATION - 07640178989009

JULIET LL BOITE B
SpineArt SA
JLL-BX 12 00-N
Not in Commercial Distribution

  • 07640178989009 ()
JLL-BX 12 00-N

  • Instrument tray, reusable

Dalbo®-B EE - 07640166513780

Dalbo®-B EE
Cendres+Métaux SA
050427
In Commercial Distribution

  • 07640166513780 ()
050427

  • Dental anchor

Aurora B Control Slides - B502BSB9023CS0

Aurora B Control Slides
BIO SB, INC.
BSB-9023-CS
In Commercial Distribution

  • B502BSB9023CS0 ()
BSB-9023-CS

  • Biological stain control IVD

FREEDOM KNEE - 00811767020251

FEMORAL, CR, RIGHT, B
MAXX ORTHOPEDICS, INC.
UFCRRB00-K
In Commercial Distribution

  • 00811767020251 ()

  • Length: 54 Millimeter
  • Width: 58 Millimeter


  • Cruciate-retaining total knee prosthesis

FREEDOM KNEE - 00811767020176

FEMORAL, CR, LEFT, B
MAXX ORTHOPEDICS, INC.
UFCRLB00-K
In Commercial Distribution

  • 00811767020176 ()

  • Width: 58 Millimeter
  • Length: 54 Millimeter


  • Cruciate-retaining total knee prosthesis

FREEDOM KNEE - 00811767020091

FEMORAL, PS, RIGHT, B
MAXX ORTHOPEDICS, INC.
UFPSRB00-K
In Commercial Distribution

  • 00811767020091 ()

  • Length: 54 Millimeter
  • Width: 58 Millimeter


  • Posterior-stabilized total knee prosthesis

FREEDOM KNEE - 00811767020015

FEMORAL, PS, LEFT, B
MAXX ORTHOPEDICS, INC.
UFPSLB00-K
In Commercial Distribution

  • 00811767020015 ()

  • Length: 54 Millimeter
  • Width: 58 Millimeter


  • Posterior-stabilized total knee prosthesis

NOVO Health Services, LLC - 00812564035615

DELRAY MINOR B PACK
NOVO HEALTH SERVICES, LLC
124987
Not in Commercial Distribution

  • 00812564035615 ()

  • Weight: 14.7 Pound
  • Width: 13.5 Inch
  • Height: 12 Inch
124987H

  • General surgical procedure kit, non-medicated, reusable

NOVO Health Services, LLC - 00812564034434

DELRAY MINOR B PACK
NOVO HEALTH SERVICES, LLC
124987
Not in Commercial Distribution

  • 00812564034434 ()

  • Weight: 14.7 Pound
  • Width: 13.5 Inch
  • Height: 12 Inch
124987G

  • General surgical procedure kit, non-medicated, reusable

Aligned Medical Solutions - B098AMS101050

BONE BIN A/B
Aligned Medical Solutions
AMS10105
In Commercial Distribution

  • B098AMS101051 ()
  • B098AMS101050 ()
AMS10105

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

Aligned Medical Solutions - B098AMS141560

CRANIAL BUNDLE PACK B
Aligned Medical Solutions
AMS14156
In Commercial Distribution

  • B098AMS141561 ()
  • B098AMS141560 ()
AMS14156

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

Aligned Medical Solutions - B098AMS14156A0

Cranial Bundle Pack B
Aligned Medical Solutions
AMS14156A
In Commercial Distribution

  • B098AMS14156A1 ()
  • B098AMS14156A0 ()
AMS14156A

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

CARDINAL HEALTH - 10198956122451

KIT, HEART PART B
Cardinal Health 200, LLC
PV43HEE16
In Commercial Distribution

  • 50198956122459 ()
  • 10198956122451 ()
PV43HEE16

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

CARDINAL HEALTH - 10198956063884

KIT, WELCOME ADMISSION B
Cardinal Health 200, LLC
AMN4226771
In Commercial Distribution

  • 50198956063882 ()
  • 10198956063884 ()
AMN4226771

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

Vintage Art - E23565270

VINTAGE ART SHADE B
SHOFU DENTAL CORPORATION
6527
In Commercial Distribution

  • E23565270 ()
6527

  • Dental appliance fabrication material, ceramic

LITE ART - E23519750

LITE ART B SHADE
SHOFU DENTAL CORPORATION
1975
In Commercial Distribution

  • E23519750 ()
1975

  • Dental unfilled resin sealant/coating

Ceramage - E23519380

Ceramage Cervical Trans. B
SHOFU DENTAL CORPORATION
1938
In Commercial Distribution

  • E23519380 ()
1938

  • Dental prosthesis veneer resin

Solidex - E23515640

SOLIDEX STAIN B, 1mL
SHOFU DENTAL CORPORATION
1564
In Commercial Distribution

  • E23515640 ()
1564

  • Dental prosthesis veneer resin

Solidex - E23515620

SOLIDEX STAIN B, 1mL
SHOFU DENTAL CORPORATION
1562
In Commercial Distribution

  • E23515620 ()
1562

  • Dental prosthesis veneer resin

CARDINAL HEALTH - 10198956087811

LUMBAR PUNCTURE PACK B
Cardinal Health 200, LLC
SAN12LPYHE
In Commercial Distribution

  • 50198956087819 ()
  • 10198956087811 ()
SAN12LPYHE

  • General surgical procedure kit, medicated

CARDINAL HEALTH - 10198956081321

CARDIAC A B PACK
Cardinal Health 200, LLC
SAN23CC135
In Commercial Distribution

  • 50198956081329 ()
  • 10198956081321 ()
SAN23CC135

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

CARDINAL HEALTH - 10198956039124

CARDIAC A B PACK
Cardinal Health 200, LLC
SAN23CC134
In Commercial Distribution

  • 50198956039122 ()
  • 10198956039124 ()
SAN23CC134

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

CARDINAL HEALTH - 10198956114333

DR B ANGIO PACK
Cardinal Health 200, LLC
SAN11DBMMA
In Commercial Distribution

  • 50198956114331 ()
  • 10198956114333 ()
SAN11DBMMA

  • Cardiothoracic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10198956103269

KIT, HEART PART B
Cardinal Health 200, LLC
PV43HEE15
In Commercial Distribution

  • 50198956103267 ()
  • 10198956103269 ()
PV43HEE15

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

PDT, Inc. - 00813677020871

Jack B. Nimble Scaler
PDT, INC.
R130 Jack B. Nimble Scaler
In Commercial Distribution

  • 00813677020871 ()
R130

  • Manual dental scaler, reusable

Medline - 00888277690175

STETHOSCOPE, SYNERGY, SINGLE-HEAD, B
MEDLINE INDUSTRIES, INC.
MDS926601
In Commercial Distribution

  • 00888277690175 ()
MDS926601

  • Mechanical external stethoscope

M.U.S.T. Pedicle Screw System - 07630542719790

Pre-Contoured Ø6 CoCr - B
Medacta International SA
03.68.968
In Commercial Distribution

  • 07630542719790 ()


  • Bone-screw internal spinal fixation system rod

M.U.S.T. Pedicle Screw System - 07630542719639

Pre-Contoured Ø6 Ti - B
Medacta International SA
03.68.951
In Commercial Distribution

  • 07630542719639 ()


  • Bone-screw internal spinal fixation system rod

IMMY - 00816387021121

MycoDDR Neutralization Buffer B
Immuno-Mycologics, Inc.
TBPN67-500
In Commercial Distribution

  • 00816387021121 ()
  • 00816387021114 ()


  • Sputum liquefaction/decontamination reagent IVD

IMMY - 00816387021107

MycoDDR Neutralization Buffer B
Immuno-Mycologics, Inc.
TBPN67
In Commercial Distribution

  • 00816387021107 ()
  • 00816387021091 ()


  • Sputum liquefaction/decontamination reagent IVD

MICROPRIME - 00816594021600

MICROPRIME B,10ML,FA
DANVILLE MATERIALS, LLC
87001
In Commercial Distribution

  • 00816594021600 ()
87001

  • Dental coating, tooth-desensitizing
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