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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4.75mm External Hex Straight Locking Implant Abutment Flat GH 1mm
TITAN IMPLANT INC
I-4.75SLIAF-02-1.0
In Commercial Distribution

  • 00842448102379 ()


  • Dental implant suprastructure, permanent, preformed
5.0mm External Hex Healing Abutment Gh 5mm Profile Dia: 6mm
TITAN IMPLANT INC
BH-5HA-B-5.0
In Commercial Distribution

  • 00842448101662 ()


  • Dental implant suprastructure, temporary, preformed, single-use
5.0mm External Hex Healing Abutment Gh 3mm Profile Dia: 6mm
TITAN IMPLANT INC
BH-5HA-B-3.0
In Commercial Distribution

  • 00842448101655 ()


  • Dental implant suprastructure, temporary, preformed, single-use
5.0mm External Hex Healing Abutment Gh 5mm Profile Dia: 5mm
TITAN IMPLANT INC
BH-5HA-A-5.0
In Commercial Distribution

  • 00842448101648 ()


  • Dental implant suprastructure, temporary, preformed, single-use
5.0mm External Hex Healing Abutment Gh 3mm Profile Dia: 5mm
TITAN IMPLANT INC
BH-5HA-A-3.0
In Commercial Distribution

  • 00842448101631 ()


  • Dental implant suprastructure, temporary, preformed, single-use
3.4mm Platform External Hex Titan Design Healing Abutment GH 3mm
TITAN IMPLANT INC
TN-34MHA-B-3.0
In Commercial Distribution

  • 00842448116130 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.1mm Platform External Hex Gold Cylinder Long Plastic Sleeve Hexed
TITAN IMPLANT INC
NB-G-41GCLPSH
In Commercial Distribution

  • 00842448115973 ()


  • Dental implant suprastructure, permanent, preformed
3.3mm External Hex Straight Locking Implant Abutment Flat GH 1mm
TITAN IMPLANT INC
I-33SLIAF-02-1.0
In Commercial Distribution

  • 00842448115393 ()


  • Dental implant suprastructure, permanent, preformed
FIXED POST MOUNT TELESCOPING ARM,W/2"CLAMP & EXTERNAL UMBILICAL
Ls Enterprises, Inc.
1075
In Commercial Distribution

  • D06910750 ()


  • Dental delivery system
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
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
Claw Reamer Bur EXternal Hex 3i/Branemark®-compatible RP
Preat Corporation
0800154
In Commercial Distribution

  • 00842092125359 ()
0800154

  • Screw extractor, single-use
ExFeel Internal & EZ External System M2/ L=20/ Regular, Wide
Megagen Implant Co. Ltd
REIG200
In Commercial Distribution

  • 08806388232529 ()
REIG200

  • Dental precision attachment simulator/analog, single-use
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
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
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
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
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
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 - SHORT TRAY
Smith & Nephew, Inc.
71067358
In Commercial Distribution

  • 03596010612120 ()
71067358

  • Instrument tray, reusable
JET-X LARGE - UNILATERAL EXTERNAL FIXATOR SYSTEM OUTER TRAY - TALL TRAY
Smith & Nephew, Inc.
71067359
In Commercial Distribution

  • 03596010608109 ()
71067359

  • Instrument tray, reusable
Curaplex Automated External Defibrillator (AED) Support Kit in Poly Bag
BOUND TREE MEDICAL, LLC
651776
In Commercial Distribution

  • 00815277021203 ()
  • 00810071639265 ()
651776

  • Dry medical towel/wipe, single-use
  • Cardiopulmonary resuscitation mask, single-use
  • Laboratory waste receptacle IVD
  • Antiseptic skin towelette
  • Safety razor, single-use
  • Bandage scissors, reusable
  • Nitrile examination/treatment glove, non-powdered, antimicrobial
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9030SP1
In Commercial Distribution

  • 10381780071136 ()
  • M269INS9030SP11 ()
INS9030SP1

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9030
In Commercial Distribution

  • 10381780071129 ()
  • M269INS90301 ()

  • 30ml
INS9030

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9020SP1
In Commercial Distribution

  • 10381780071112 ()
  • M269INS9020SP11 ()

  • 20ml
INS9020SP1

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
LimiTorr™ Volume Limiting External CSF Drainage and Monitoring System
Integra Lifesciences Corporation
INS9020
In Commercial Distribution

  • 10381780071105 ()
  • M269INS90201 ()

  • 20ml
INS9020

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Hermetic™ II External CSF Drainage Management Replacement Collection Bag
Integra Lifesciences Corporation
NL8508305N
In Commercial Distribution

  • 30381780071659 ()
  • 10381780071655 ()
  • M269NL8508305N1 ()

  • 700 ml
NL8508305N

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
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
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
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
Male External Catheter,Texas Style, Standard Size, Take Home Pack
Cardinal Health, Inc.
8884731300
Not in Commercial Distribution

  • 10884521003989 ()
  • 20884521003986 ()
  • 30884521003983 ()

  • Outer Diameter: 1.375 Inch
8884731300

  • Indwelling urethral catheterization kit, adult
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