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

  • 10888277842144 ()
  • 40888277842145 ()
DYNJBIPLR09A

  • General surgical procedure kit, non-medicated, reusable
ARCHITECT i1000sr System e-Assay CD ROM
ABBOTT LABORATORIES
4P57-22
Not in Commercial Distribution

  • 00380740157067 ()
04P5722

  • Laboratory instrument/analyser application software IVD
0800,APS1,08,N,TV,CU,CD
CURBELL MEDICAL PRODUCTS, INC.
3800-485
In Commercial Distribution

  • 00840828149570 ()
15200

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

  • 50885425298233 ()
  • 10885425298235 ()
SNE23NAUCN

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

  • 10846446032208 ()
26322-001

  • Home-use sleep apnoea recording system
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 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
2330 RESTING EKG ELECT 10EA/CD
3M COMPANY
2330
In Commercial Distribution

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

  • Electrocardiographic electrode, single-use
FLSS 40M EX COMF MNT CD
PUBLIX SUPER MARKETS, INC.
2G5
In Commercial Distribution

  • 00041415090729 ()


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

  • 00841494103972 ()
IEC-MJ21

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Sandman Elite 9.3 Install CD ENU
Embla Systems Ltd
4283000
In Commercial Distribution

  • 00382830043533 ()


  • Sleep disorder interpretive software
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
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
A600BLUE CD COSSETTE ET RUEL 1P
Peter Brasseler Holdings, LLC
5026413U0
In Commercial Distribution

  • 00887919797470 ()


  • Diamond dental bur, single-use
A100RED CD FORTIN ET LEBLOND 1P
Peter Brasseler Holdings, LLC
5025419U0
In Commercial Distribution

  • 00887919756750 ()


  • Diamond dental bur, single-use
NYU CD CLINIC 7W CROWN & BRIDGE
Peter Brasseler Holdings, LLC
5029443U0
In Commercial Distribution

  • 00887919921639 ()


  • Diamond dental bur, single-use
A637RED CD&D'IMPL DR JF LEMELIN
Peter Brasseler Holdings, LLC
5028225U0
In Commercial Distribution

  • 00887919868668 ()


  • Diamond dental bur, single-use
A637BLU CD FORTIN ET LEBLOND 1P
Peter Brasseler Holdings, LLC
5027470U0
In Commercial Distribution

  • 00887919843443 ()


  • Diamond dental bur, single-use
CAL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008791
In Commercial Distribution

  • 00810042684423 ()
18008791

  • Multiple drugs of abuse IVD, control
CAL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008790
In Commercial Distribution

  • 00810042684416 ()
18008790

  • Multiple drugs of abuse IVD, control
CD 660IMS SOFTWARE UPGRADE VER 1.5
Smith & Nephew, Inc.
72201078
In Commercial Distribution

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system
CARVER DE CD W-A-C-D- STD HDL
NORDENT MANUFACTURING INC
CAWACD
In Commercial Distribution

  • 00840018629356 ()


  • Dental restoration carver, amalgam, reusable
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
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, Service Manual Propaq CS, 24X
WELCH ALLYN, INC.
901062
In Commercial Distribution

  • 00732094061420 ()
810-1657-02

  • Electrocardiographic lead set, reusable
CD 9732463 INSTALL U ITHR INAV
MEDTRONIC NAVIGATION, INC.
9732463
In Commercial Distribution

  • 00885074510484 ()


  • Orthopaedic stereotactic surgery system
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
RPL MMT-7741 IPRO2 RJ BATTERY CD
MEDTRONIC MINIMED, INC.
MMT-7741
In Commercial Distribution

  • 00763000049492 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
RPL MMT-7821LNA GST4C LOCKOUT EN CD
MEDTRONIC MINIMED, INC.
MMT-7821LNA
In Commercial Distribution

  • 00763000398330 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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