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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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AESCULAP - 04038653065066

Aorta Punch, 5 1/2", (140 mm), diam. 5 mm, non-sterile, reusable
Aesculap AG
FB195R
In Commercial Distribution

  • 04038653065066 ()
FB195R

  • Aorta punch, reusable

SAVANNAH-T - 00840916101510

5 5 x 50mm, Savannah®-T, DualFix Cortical-Cancellous Screw, Cannulated, High-Top,
SPINAL ELEMENTS
10-03-5550-52
In Commercial Distribution

  • 00840916101510 ()


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

JMU - 00840456208151

JMU Carbide Burs, Round, RA #5, 5/pk (ISO No. 001/016)
JMU DENTAL, INC
14401005
In Commercial Distribution

  • 00840456208151 ()


  • Carbide dental bur, reusable

JMU - 00840456207741

JMU Carbide Burs, Round, FG #5, 5/pk (ISO No. 001/016)
JMU DENTAL, INC
14001007
In Commercial Distribution

  • 00840456207741 ()


  • Carbide dental bur, reusable

Avalign - 00190776043797

Guilford-Wright Duckbill Elevator, curved blade, BW 3.5mm, OL 143mm (5 5/8")
Avalign Technologies, Inc.
VM101-4212
In Commercial Distribution

  • 00190776043797 ()


  • Bone lever/elevator, reusable

AoN Implants - 00840192705334

Sleeve for Guided Surgery D.5 mm. B5 - Peek - pack of 5.
FAICO MEDICAL LLC
ACG50000BCPP0
Not in Commercial Distribution

  • 00840192705334 ()


  • Dental implant system

AoN Implants - 00840192705310

Sleeve for Guided Surgery D.5 mm. B5 - Titanium - pack of 5.
FAICO MEDICAL LLC
ACG50000BCTT0
Not in Commercial Distribution

  • 00840192705310 ()


  • Dental implant system

Ambler Surgical - 00190660021368

Converse sweeper curette, 5 5/8'', 4.0mm x 9.0mm cup, brun handle
AMBLER SURGICAL CORP.
Converse sweeper curette
In Commercial Distribution

  • 00190660021368 ()
19-420

  • Endaural surgical curette, reusable

Marina Medical - 00840306806438

Denniston Double Ended Dilators, Set of 5 , 5/6 - 13/14mm, 29cm
MARINA MEDICAL INSTRUMENTS, INC.
260-010
In Commercial Distribution

  • 00840306806438 ()
260-010

  • Vascular dilator, reusable

Medicon - 04046826129040

Ti mandib reco locking plate lf+rt ang 5+19+5 holes
Medicon eG. Chirurgiemechaniker-Genossenschaft
68.98.85
In Commercial Distribution

  • 04046826129040 ()
68.98.85

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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