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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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Medline Industries, Inc. - 10888277842700

FCP BIPOLAR BAYONET 7 CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR19A
In Commercial Distribution

  • 10888277842700 ()
  • 40888277842701 ()
DYNJBIPLR19A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277842144

FCP BIPOLAR 4.5 UNCTD CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR09A
In Commercial Distribution

  • 10888277842144 ()
  • 40888277842145 ()
DYNJBIPLR09A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277841468

FCT BAYONET 8" .75MM CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR01A
In Commercial Distribution

  • 10888277841468 ()
  • 40888277841469 ()
DYNJBIPLR01A

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10888277804463

TAPE MEDI-STRIP 1/4X4IN 5/CD
MEDLINE INDUSTRIES, INC.
DYNJZ29750
In Commercial Distribution

  • 40888277804464 ()
  • 10888277804463 ()
DYNJZ29750

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

Medline Industries, Inc. - 10888277804456

TAPE MEDI-STRIP 1/2X4IN 3/CD
MEDLINE INDUSTRIES, INC.
DYNJZ29749
In Commercial Distribution

  • 40888277804457 ()
  • 10888277804456 ()
DYNJZ29749

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

WAVESCAN OFFLINE PROGRAMMING MODULE - 05050474591905

INSTALL CD,WS 3.68,OPM,US
JOHNSON & JOHNSON SURGICAL VISION, INC.
0070-2533
Not in Commercial Distribution

  • 05050474591905 ()
0070-2533

  • Laser application software

BioPlex 2200 - 03610520506431

BioPlex 2200 Lyme Total Control CD
BIO-RAD LABORATORIES, INC.
12000880
In Commercial Distribution

  • 03610520506431 ()

  • 1 Each
12000880

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control

BioPlex 2200 - 03610520506417

BioPlex 2200 Lyme Total Calibrator CD
BIO-RAD LABORATORIES, INC.
12000878
In Commercial Distribution

  • 03610520506417 ()

  • 1 Each
12000878

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, calibrator

660 - 03596010579591

CD 660IMS SOFTWARE UPGRADE VER 1.5
Smith & Nephew, Inc.
72201078
In Commercial Distribution

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system

0800,APS1,08,N,TV,CU,CD - 00840828149570

0800,APS1,08,N,TV,CU,CD
CURBELL MEDICAL PRODUCTS, INC.
3800-485
In Commercial Distribution

  • 00840828149570 ()
15200

  • Pillow speaker

Red Dot™ - 10707387195455

2330 RESTING EKG ELECT 10EA/CD
3M COMPANY
2330
In Commercial Distribution

  • 50707387195453 ()
  • 10707387195455 ()
  • 00707387195458 ()
2330

  • Electrocardiographic electrode, single-use

Publix - 00041415090729

FLSS 40M EX COMF MNT CD
PUBLIX SUPER MARKETS, INC.
2G5
In Commercial Distribution

  • 00041415090729 ()


  • Dental floss

CARDINAL HEALTH - 10885425298235

STRL NEURO ANGIO CD 050295 PK
Cardinal Health 200, LLC
SNE23NAUCN
In Commercial Distribution

  • 50885425298233 ()
  • 10885425298235 ()
SNE23NAUCN

  • Angiography kit

Siemens - 04046355636255

Siemens UNITY 2 CD CABLE 3M
Ws Audiology Usa, Inc.
UNITY 2 CD CABLE 3M
Not in Commercial Distribution

  • 04046355636255 ()
10668689

  • Audiometric/hearing aid tester

Somnostar - 10846446032208

LABMANAGER WORD 2013 REPORT HOTFIX CD
Carefusion Corporation
26322-001
Not in Commercial Distribution

  • 10846446032208 ()
26322-001

  • Home-use sleep apnoea recording system

syngo Dynamics - 04056869058917

syngo Dynamics VA20C product label - CD
Siemens Healthcare GmbH
10744847
In Commercial Distribution

  • 04056869058917 ()


  • Radiological PACS software

Xltek - 00382830043533

Sandman Elite 9.3 Install CD ENU
Embla Systems Ltd
4283000
In Commercial Distribution

  • 00382830043533 ()


  • Sleep disorder interpretive software

ARCHITECT - 00380740157067

ARCHITECT i1000sr System e-Assay CD ROM
ABBOTT LABORATORIES
4P57-22
Not in Commercial Distribution

  • 00380740157067 ()
04P5722

  • Laboratory instrument/analyser application software IVD

Accuguide® - 00613994161635

SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
MEDTRONIC XOMED, INC.
8263005
In Commercial Distribution

  • 00613994161635 ()


  • Nerve-locating system

MICROSTAN MONOPOLAR FORCEPS - 00841494103972

MICROSTAN MONOPOLAR FORCEPS,CABLE&CD IEC
Cynosure, LLC
IEC-MJ21
In Commercial Distribution

  • 00841494103972 ()
IEC-MJ21

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

BioPlex 2200 - 00847865010955

Vasculitis Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1 V1
In Commercial Distribution

  • 00847865010955 ()

  • 1 Each
6651870E

  • Multiple vasculitis-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865002394

Vasculitis Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002394 ()

  • 1 Each
6651870D

  • Multiple vasculitis-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865002288

Anti-CCP Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002288 ()

  • 1 Each
6653270D

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

BioPlex 2200 - 00847865000826

CD, BioPlex Anti-CCP Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6633220
In Commercial Distribution

  • 00847865000826 ()

  • 1 Each
6633220

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibrator

MEDI - 00636257025932

PROFILE ARM OVERSLEEVE NO GAUNTLET C-D
MEDI MANUFACTURING, INC.
CFAMSCV3
In Commercial Distribution

  • 00636257025932 ()


  • Compression bandaging kit

NORDENT MANUFACTURING INC - 00840018629356

CARVER DE CD W-A-C-D- STD HDL
NORDENT MANUFACTURING INC
CAWACD
In Commercial Distribution

  • 00840018629356 ()


  • Dental restoration carver, amalgam, reusable

Brasseler USA - 00887919843443

A637BLU CD FORTIN ET LEBLOND 1P
Peter Brasseler Holdings, LLC
5027470U0
In Commercial Distribution

  • 00887919843443 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919921639

NYU CD CLINIC 7W CROWN & BRIDGE
Peter Brasseler Holdings, LLC
5029443U0
In Commercial Distribution

  • 00887919921639 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919868668

A637RED CD&D'IMPL DR JF LEMELIN
Peter Brasseler Holdings, LLC
5028225U0
In Commercial Distribution

  • 00887919868668 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919797470

A600BLUE CD COSSETTE ET RUEL 1P
Peter Brasseler Holdings, LLC
5026413U0
In Commercial Distribution

  • 00887919797470 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919756750

A100RED CD FORTIN ET LEBLOND 1P
Peter Brasseler Holdings, LLC
5025419U0
In Commercial Distribution

  • 00887919756750 ()


  • Diamond dental bur, single-use

N/A - 00885074510484

CD 9732463 INSTALL U ITHR INAV
MEDTRONIC NAVIGATION, INC.
9732463
In Commercial Distribution

  • 00885074510484 ()


  • Orthopaedic stereotactic surgery system

DETECTABUSE - 00810042684423

CAL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008791
In Commercial Distribution

  • 00810042684423 ()
18008791

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042684416

CAL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008790
In Commercial Distribution

  • 00810042684416 ()
18008790

  • Multiple drugs of abuse IVD, control

CD HORIZON® Spinal System - 00721902551215

4.5 X50MM CD HORIZON F.A SCRW
MEDTRONIC SOFAMOR DANEK, INC.
8574550
Not in Commercial Distribution

  • 00721902551215 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 50.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® Spinal System - 00721902551208

4.5 X45MM CD HORIZON F.A SCRW
MEDTRONIC SOFAMOR DANEK, INC.
8574545
Not in Commercial Distribution

  • 00721902551208 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 45.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® Spinal System - 20673978007643

SCREW 110300 BABY CD SELF BRKNG
MEDTRONIC SOFAMOR DANEK, INC.
110300
Not in Commercial Distribution

  • 20673978007643 ()
  • 00673978007649 ()


  • Bone-screw internal spinal fixation system, non-sterile

Welch Allyn, Inc. - 00732094061420

CD, Service Manual Propaq CS, 24X
WELCH ALLYN, INC.
901062
In Commercial Distribution

  • 00732094061420 ()
810-1657-02

  • Electrocardiographic lead set, reusable

Guardian™ Connect - 00763000398330

RPL MMT-7821LNA GST4C LOCKOUT EN CD
MEDTRONIC MINIMED, INC.
MMT-7821LNA
In Commercial Distribution

  • 00763000398330 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Guardian ™ Link (3) - 00763000389024

STRT KIT MMT-7810NA GST3C 2.2A CD
MEDTRONIC XOMED, INC.
MMT-7810NA
In Commercial Distribution

  • 00763000389024 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

iPro™ 2 - 00763000049492

RPL MMT-7741 IPRO2 RJ BATTERY CD
MEDTRONIC MINIMED, INC.
MMT-7741
In Commercial Distribution

  • 00763000049492 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Persona® The Personalized Knee System - 00889024441118

No Description
Zimmer, Inc.
00-5907-083-77
In Commercial Distribution

  • 00889024441118 ()

  • 4-9 CD Right
00-5907-083-77

  • Device sterilization/disinfection container, reusable

Persona® The Personalized Knee System - 00889024441071

No Description
Zimmer, Inc.
00-5907-083-72
In Commercial Distribution

  • 00889024441071 ()

  • 4-9 CD Left
00-5907-083-72

  • Device sterilization/disinfection container, reusable

Persona® The Personalized Knee® - 00889024245761

No Description
Zimmer, Inc.
42-5279-003-02
In Commercial Distribution

  • 00889024245761 ()

  • 12mmThickness, Size CD
42-5279-003-02

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245471

No Description
Zimmer, Inc.
42-5276-005-10
In Commercial Distribution

  • 00889024245471 ()

  • Size 6-9 CD
42-5276-005-10

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245457

No Description
Zimmer, Inc.
42-5276-004-10
In Commercial Distribution

  • 00889024245457 ()

  • Size 3-5 CD
42-5276-004-10

  • Knee tibia prosthesis trial, reusable

PERSONA™ - 00889024245433

No Description
Zimmer, Inc.
42-5276-003-10
In Commercial Distribution

  • 00889024245433 ()

  • Size 1-2 CD
42-5276-003-10

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245310

No Description
Zimmer, Inc.
42-5274-005-10
In Commercial Distribution

  • 00889024245310 ()

  • Size 6-9 CD
42-5274-005-10

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245303

No Description
Zimmer, Inc.
42-5274-004-10
In Commercial Distribution

  • 00889024245303 ()

  • Size 3-5 CD
42-5274-004-10

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245297

No Description
Zimmer, Inc.
42-5274-003-10
In Commercial Distribution

  • 00889024245297 ()

  • Size 1-2 CD
42-5274-003-10

  • Knee tibia prosthesis trial, reusable
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