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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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Rect 10" x 16" Phantom Co 57
RADQUAL, LLC
BM07
In Commercial Distribution

  • 00850020470044 ()


  • Nuclear medicine phantom, flood source
Rect 14" x 18" Phantom Co 57
RADQUAL, LLC
BM04
In Commercial Distribution

  • 00850020470020 ()


  • Nuclear medicine phantom, flood source
7106-7375 JET-X 4 HOLE PIN CLAMPMR CO
MEDLINE INDUSTRIES, INC.
71067375RH
In Commercial Distribution

  • 10193489002539 ()
71067375RH

  • External orthopaedic fixation system reprocessed component
7106-4009 JET-X BAR TO PIN CLAMPMR CO
MEDLINE INDUSTRIES, INC.
71064009RH
In Commercial Distribution

  • 10193489002348 ()
71064009RH

  • External orthopaedic fixation system reprocessed component
CONNECTOR G7755327 OFFSET LP OC SCREW CO
MEDTRONIC SOFAMOR DANEK, INC.
G7755327
In Commercial Distribution

  • 00613994666901 ()

  • Large


  • Bone-screw internal spinal fixation system connector
7106-7376 JET-X 6 HOLE PIN CLAMPMR CO
MEDLINE INDUSTRIES, INC.
71067376RH
In Commercial Distribution

  • 10193489002546 ()
71067376RH

  • External orthopaedic fixation system reprocessed component
KIT,ANE UNIV OF CO 30 CS
Cardinal Health 200, LLC
ANE4588111
In Commercial Distribution

  • 50887488981725 ()
  • 10887488981727 ()
ANE4588111

  • General surgical procedure kit, non-medicated, single-use
SAMPLING LINE, 10ft, Co/Ext, M/M
King Systems Corporation
7073
In Commercial Distribution

  • 00612649112183 ()
  • 00612649191065 ()
7073

  • Gas-sampling/monitoring respiratory tubing, single-use
SAMPLING LINE, 10ft, Co/Ext, M/F
King Systems Corporation
7031
In Commercial Distribution

  • 00612649112039 ()
  • 00612649190990 ()
7031

  • Gas-sampling/monitoring respiratory tubing, single-use
KIT,ANE UNIV OF CO 30 CS
Cardinal Health 200, LLC
ANE4588112
In Commercial Distribution

  • 50888439625415 ()
  • 10888439625417 ()
ANE4588112

  • General surgical procedure kit, non-medicated, single-use
PK CUST CV A&B CABRINI CO
MEDLINE INDUSTRIES, INC.
DYNJ60583
In Commercial Distribution

  • 10193489523676 ()
DYNJ60583

  • General surgical procedure kit, non-medicated, single-use
Pathotec CO 100/PK (25/vial-4vial/PK)
REMEL, INC.
R38191
In Commercial Distribution

  • 00848838031151 ()
R38191

  • Bacterial species differentiation disc IVD
PK CUST CV A&B CABRINI CO
MEDLINE INDUSTRIES, INC.
DYNJ60583A
In Commercial Distribution

  • 10193489391046 ()
DYNJ60583A

  • General surgical procedure kit, non-medicated, single-use
DBD-LAP,APPLIER,LIGACLIP,ROT,ETHI,MED,CO
MEDLINE INDUSTRIES, INC.
MDS708741EM
In Commercial Distribution

  • 10884389183397 ()
MDS708741EM

  • Flexible endoscopic tissue manipulation forceps, reusable
ENNOVATE MIS C-RING FOR CO/DI DEVICE
Aesculap AG
SZ395R
In Commercial Distribution

  • 04046964720338 ()
SZ395R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Personal Use Kit OC-Auto, for Denver, CO
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 2333555
In Commercial Distribution

  • 00816917021836 ()


  • Faecal occult blood IVD, reagent
ENNOVATE TRAY OPEN BELOW SCRW.HEAD CO/DI
Aesculap AG
SZ221R
In Commercial Distribution

  • 04046955198252 ()
SZ221R

  • Surgical instrument/implant rack
KIT,ANE UNIV OF CO 30 CS
Cardinal Health 200, LLC
ANE458811D
In Commercial Distribution

  • 50885425102004 ()
  • 10885425102006 ()
ANE458811D

  • General surgical procedure kit, non-medicated, single-use
HS27 HFF W96/48 EVERY OTHER CO
DIAGNOSTIC HYBRIDS, INC.
87-9648C
In Commercial Distribution

  • 30014613334545 ()
87-9648C

  • Cell culture line IVD
KIT DECOMPRESSION KIT FOR QUEEN ANNE'S CO
BOUND TREE MEDICAL, LLC
QASEEPNEK
In Commercial Distribution

  • 00812277033748 ()
QASEEPNEK

  • Pneumothorax catheter insertion set
*Custom* Kent CO DE IV Start Kit
BOUND TREE MEDICAL, LLC
8600-01437
In Commercial Distribution

  • 00812277036145 ()
8600-01437

  • Peripheral intravenous catheterization support kit
LUM LAM CUSTOM PACK F/ CO CUSTOM
HENRY SCHEIN, INC.
5702914
In Commercial Distribution

  • 00304040168257 ()
  • 10304040168254 ()
5702914

  • General surgical procedure kit, non-medicated, single-use
KUP2 KOIS UNIV CO (M) FL 3P
Peter Brasseler Holdings, LLC
5030930U0
In Commercial Distribution

  • 00887919964988 ()


  • Dental abrasive point, reusable
CUSTOM PACK BB10R23R1 5PK GV DELNIDO CO
MEDTRONIC, INC.
BB10R23R1
In Commercial Distribution

  • 20763000446400 ()
  • 00763000446390 ()


  • Cardiopulmonary bypass system blood tubing set
X LARGE RADIAL HEAD PROSTHESIS - CO CR
Smith & Nephew, Inc.
71927097
Not in Commercial Distribution

  • 00885556044629 ()
71927097

  • Elbow radius prosthesis
Chang Hydrodissection Cannula 27 Gauge Flat Tip Angled 90° with beveled opening Standard Short Tip 1.5mm Length
Med Saver, Inc.
11-8-6575
In Commercial Distribution

  • 00194613052119 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 90" RIBBON LEADWIRE (6-LEAD), COLOR GROUP R1
ROCHESTER ELECTRO-MEDICAL, INC.
S96090-R1
Not in Commercial Distribution

  • 10816843022416 ()


  • Subdermal needle electrode
DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 2.3 M (90") TWISTED LEADWIRE, COLOR GROUP 1
ROCHESTER ELECTRO-MEDICAL, INC.
S06666-P
Not in Commercial Distribution

  • 10816843021662 ()
  • 10816843021655 ()


  • Subdermal needle electrode
DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C
ROCHESTER ELECTRO-MEDICAL, INC.
S03355-90S
Not in Commercial Distribution

  • 10816843021648 ()


  • Subdermal needle electrode
Laparoscopic Electrode with a 3/32 In. pin connector, STRAIGHT BLADE, 5 mm x 27 cm
Conmed Corporation
60-5160-002
In Commercial Distribution

  • 20653405009686 ()
  • 30653405009683 ()
  • 00653405009682 ()

  • Outer Diameter: 5 Millimeter
  • Length: 27 Centimeter
60-5160-002

  • Endoscopic electrosurgical electrode, monopolar, single-use
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
40057190 Cross-Link Assembly with Anodized Hook ø=3.0 L=90
In Commercial Distribution

  • 04719873027576 ()


  • Bone-screw internal spinal fixation system connector
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
41002090 Rod with Taper Tips, Pre-bent ø=5.5 L=90
In Commercial Distribution

  • 04719873026548 ()


  • Bone-screw internal spinal fixation system rod
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
41000090 Rod with Taper Tips, Straight ø=5.5 L=90
In Commercial Distribution

  • 04719873026241 ()


  • Bone-screw internal spinal fixation system rod
#1/2 DE Cleoid-Discoid,#7 Hdl
HU-FRIEDY MFG. CO., LLC
CD1/27
In Commercial Distribution

  • 10889950135676 ()


  • Dental restoration carver, amalgam, reusable
Lingual Weingart Pliers - 90 degrees
HU-FRIEDY MFG. CO., LLC
678-702-90
In Commercial Distribution

  • 10889950003968 ()
678-702-90

  • Orthodontic pliers
BLADE GLOVE NUMBER 11 S.S.
MEDLINE INDUSTRIES, INC.
MDS15411
In Commercial Distribution

  • 40080196652533 ()
  • 10080196652532 ()
MDS15411

  • Scalpel handle, single-use
BLADE GLOVE NUMBER 10 S.S.
MEDLINE INDUSTRIES, INC.
MDS15410
In Commercial Distribution

  • 40080196652519 ()
  • 10080196652518 ()
MDS15410

  • Scalpel handle, single-use
Lockhart-Mumery Fistula Probe number 3
Avalign Technologies, Inc.
VM21-6715
In Commercial Distribution

  • 00190776213374 ()


  • Fistula probe
Lockhart-Mumery Fistula Probe number 2
Avalign Technologies, Inc.
VM21-6713
In Commercial Distribution

  • 00190776213367 ()


  • Fistula probe
Lockhart-Mumery Fistula Probe number 1
Avalign Technologies, Inc.
VM21-6711
In Commercial Distribution

  • 00190776213350 ()


  • Fistula probe
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