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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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Integra® External Fixation System The universal bolt tubular wrench is used to tighten bolts and other parts in the external fixation system.
Ascension Orthopedics, Inc.
12224504
In Commercial Distribution

  • M269122245041 ()
  • 10381780248071 ()

  • 168.96 mm L; 10.1 mm opening
12224504

  • External orthopaedic fixation system, reusable
Flight Air Motor - 1:1 Drive - 20K - External Water Spray
Flight Dental Systems
F-424BM
In Commercial Distribution

  • D884F424BM1 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
External Abutment for Screw, 5.0 x 5mm, 15 Degree Angle
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS505-15
Not in Commercial Distribution

  • 00847236002749 ()


  • Dental implant suprastructure, permanent, preformed
External Abutment for Screw, 4.0 x 5mm, 25 Degree Angle
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS405-25
Not in Commercial Distribution

  • 00847236002732 ()


  • Dental implant suprastructure, permanent, preformed
External Abutment for Screw, 4.0 x 5mm, 15 Degree Angle
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS405-15
Not in Commercial Distribution

  • 00847236002725 ()


  • Dental implant suprastructure, permanent, preformed
External Abutment for Screw, 3.5 x 5mm, 17 Degree Angle
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS355-17
Not in Commercial Distribution

  • 00847236002695 ()


  • Dental implant suprastructure, permanent, preformed
PARA Cross Pin External Fixation Frame and One Tightening Tool
A.M. SURGICAL, INC.
8800-10
In Commercial Distribution

  • 00857915007606 ()
N/A

  • External orthopaedic fixation system, single-use, sterile
A waterproof, flexible dressing to cover wounds or external devices.
Silverceuticals Inc
4x4
In Commercial Distribution

  • 00850039735226 ()


  • Adhesive bandage
A waterproof, flexible dressing to cover wounds or external devices.
Silverceuticals Inc
4x12
Not in Commercial Distribution

  • 00850039735035 ()


  • Adhesive bandage
microTargeting(TM) Guideline 4000(TM) 5.0 High Performance External Speaker
FHC, INC.
C0237-00735
In Commercial Distribution

  • 00873263007358 ()
C0237

  • Neurophysiologic monitoring system
Hermetic™ II External CSF Drainage Management Replacement Collection Bag
Integra Lifesciences Corporation
NL8508305N
In Commercial Distribution


  • 700 ml
NL8508305N

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-46E
In Commercial Distribution

  • 00816734022405 ()
  • B019ZPNBS46E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-46E

  • Manometric gastrointestinal motility analysis system
Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZIN-BS-45E
In Commercial Distribution

  • 00816734022337 ()
  • B019ZINBS45E0 ()

  • Catheter Gauge: 6.4 French
ZIN-BS-45E

  • Manometric gastrointestinal motility analysis system
Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BG-44E
In Commercial Distribution

  • 00816734022290 ()
  • B019ZANBG44E0 ()

  • Catheter Gauge: 6.4 French
ZAN-BG-44E

  • Manometric gastrointestinal motility analysis system
JET-X LARGE - UNILATERAL EXTERNAL FIXATOR SYSTEM OUTER TRAY - TALL TRAY
Smith & Nephew, Inc.
71067359
In Commercial Distribution

  • 03596010608109 ()
71067359

  • Instrument tray, reusable
JET-X LARGE - UNILATERAL EXTERNAL FIXATOR SYSTEM OUTER TRAY - SHORT TRAY
Smith & Nephew, Inc.
71067358
In Commercial Distribution

  • 03596010612120 ()
71067358

  • Instrument tray, reusable
ATTUNE MAKE TO ORDER 3 HOLE EXTERNAL ROTATION GUIDE Assembly
DEPUY ORTHOPAEDICS, INC.
2999-67-013
In Commercial Distribution

  • 10603295552734 ()
299967013

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECIALIST MAKE TO ORDER ANTERIOR MEASURED SIZER WITH EXTERNAL ROTATION
DEPUY ORTHOPAEDICS, INC.
2999-66-647
In Commercial Distribution

  • 10603295522959 ()
299966647

  • Surgical implant template, reusable
Lid for basket DJ-4561-SPEC (External dimensions: 770 x 250 mm)
EFER ENDOSCOPY
DJ-4586-SPEC
In Commercial Distribution

  • G006DJ4586SPEC142 ()


  • Rigid optical bronchoscope
Lid for basket DJ-4561 (External dimensions: 540 x 250 mm)
EFER ENDOSCOPY
DJ-4886
In Commercial Distribution

  • G006DJ45861733 ()


  • Rigid optical bronchoscope
SIMPLE TEMP.POST PEEK EXTERNAL PROF,REP, PREKOH TG WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-MPSP-W
In Commercial Distribution

  • D7700874853 ()
A-TG-MPSP-W

  • Dental implant suprastructure, permanent, preformed
Male External Catheter, X-Large 41mm, Non Latex w/Skin wipe
The Lighthouse For The Blind
Ultra Flex XL w/wipe
In Commercial Distribution

  • 00009235421871 ()
2204045

  • Urinary incontinence penis sheath/port, single-use
Male External Catheter, Small 25 mm, Non-Latex w/Skin Wipe
The Lighthouse For The Blind
UltraFlex Small w/ wipe
In Commercial Distribution

  • 00009235421796 ()
2204037

  • Urinary incontinence penis sheath/port, single-use
Corning 2mL External Threaded Polypropylene Cryogenic Vial with Round Bottom
Corning Incorporated
430661
In Commercial Distribution

  • H1084306613 ()
  • H1084306611 ()
  • H1084306610 ()
430661

  • General specimen container IVD, no additive/medium
Male External Catheter,Standard, 2-Sided Adhesive and Skin Protective Wipe
Cardinal Health, Inc.
8884732598
In Commercial Distribution

  • 20884521025674 ()
  • 10884521025677 ()

  • Outer Diameter: 1.375 Inch
8884732598

  • Ureteral catheter
4.1mm External Hex Healing Abutment GH 8mm Profile Dia: 6.0mm
TITAN IMPLANT INC
T-4HA-D-8.0
In Commercial Distribution

  • 00842448110350 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.1mm External Hex Healing Abutment GH 6mm Profile Dia: 6.0mm
TITAN IMPLANT INC
T-4HA-D-6.0
In Commercial Distribution

  • 00842448110343 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.1mm External Hex Healing Abutment GH 4mm Profile Dia: 6.0mm
TITAN IMPLANT INC
T-4HA-D-4.0
In Commercial Distribution

  • 00842448110336 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.1mm External Hex Healing Abutment GH 2.5mm Profile Dia: 6.0mm
TITAN IMPLANT INC
T-4HA-D-2.5
In Commercial Distribution

  • 00842448110329 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.1mm External Hex Healing Abutment GH 6mm Profile Dia: 5.0mm
TITAN IMPLANT INC
T-4HA-C-6.0
In Commercial Distribution

  • 00842448110312 ()


  • Dental implant suprastructure, temporary, preformed, single-use
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