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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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ONE Extreme Ribs Bulk case male latex condom - 20726893112746

ONE Extreme Ribs Bulk case male latex condom, case of 1000
GLOBAL PROTECTION CORP.
112500C
In Commercial Distribution

  • 80726893112748 ()
  • 20726893112746 ()


  • Basic male condom, Hevea-latex

HNM MEDICAL - 00842962160183

OPTICAL CASE PLASTIC AUTOCLAVABLE, 18"X3"X2", W/SILICONE MAT, 1 CASE
HNM STAINLESS, LLC.
HNM-9-20-0121
In Commercial Distribution

  • 00842962160183 ()
HNM-9-20-0121

  • Surgical instrument interim-placement holder, reusable

HNM MEDICAL - 00842962160046

AUTOCLAVABLE CASE, 10"X6"X7", W/SILICONE STRIPS CASE, 10 SMALL CAVITIES
HNM STAINLESS, LLC.
HNM-9-20-0108
In Commercial Distribution

  • 00842962160046 ()
HNM-9-20-0108

  • Surgical instrument interim-placement holder, reusable

Phantom® Fibula Nail System - 00889795146304

Phantom Fibula Nail System, Case 1 of 1, Cannulated Reamer Case Base
Paragon 28, Inc.
P36-900-FIB3
In Commercial Distribution

  • 00889795146304 ()
P36-900-FIB3

  • Device sterilization/disinfection container, reusable

Dual EMG Wet Gel Ag/AgCl Electrode - 00816271020322

Dual EMG Wet Gel Ag/AgCl Electrode Case 200 pcs per case
Noraxon U.S.A., Inc.
272CASE
In Commercial Distribution

  • 00816271020322 ()


  • Kinesiology/electromyographic sensor set

APEX-DL Spine System - 00193082052149

APEX-DL Mono and Uniplanar Reduction DL Screws Case -Case and Lid Only-
SPINECRAFT, LLC
6000-720-DL
In Commercial Distribution

  • 00193082052149 ()
6000-720-DL

  • General internal orthopaedic fixation system implantation kit

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material - D0026057001

Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set, Case of 12 pouches
DENTSPLY INTERNATIONAL INC.
605700
In Commercial Distribution

  • D0026057001 ()
  • D0026057000 ()

  • Weight: 454 Gram
  • Case of 12 Pouches Fast Set (454g each)
605700

  • Alginate dental impression material

Jeltrate® Dustless Alginate Impression Material - D0026052201

Jeltrate® Dustless Alginate Impression Material, Fast Set, 20 pouches
DENTSPLY INTERNATIONAL INC.
605220
In Commercial Distribution

  • D0026052201 ()
  • D0026052200 ()

  • Weight: 454 Gram
  • Case of 20 Pouches, Fast Set, (454g each)
605220

  • Alginate dental impression material

N/A - 00889024437098

No Description
Zimmer, Inc.
5225-80
In Commercial Distribution

  • 00889024437098 ()

  • Size 54 mm and 74 mm Case Set


  • Device sterilization/disinfection container, reusable

NA - 00889024181106

No Description
Zimmer, Inc.
9363-99-130
In Commercial Distribution

  • 00889024181106 ()

  • 28 mm Standard, and Hooded Insert Trial Case
9363-99-130

  • Device sterilization/disinfection container, reusable

NA - 00889024181915

No Description
Zimmer, Inc.
9368-99-180
In Commercial Distribution

  • 00889024181915 ()

  • 32 mm Standard and, Hooded Insert Trial Case
9368-99-180

  • Device sterilization/disinfection container, reusable

ROSPITAL PRODUCTOS MEDICOS - 00812460021484

ELECTROSURGICAL PLATE EA. 20PCS/BOX. 10 BOXES/CASE
ATLAS MEDICAL PRODUCTS LLC
ELSP
In Commercial Distribution

  • 00812460021484 ()
  • 10812460021481 ()
  • 20812460021488 ()

  • ELECTROSURGICAL PLATE EA. 20PCS/BOX. 10 BOXES/CASE
ELSP

  • Electrosurgical return electrode, single-use

HEPRO.US Welcome Pack - Case - 00854427007988

1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with Elastic 160x 240cm - 30 Non-Sterile Pouch Copy
HEPRO.US INC.
CT - Welcome Pack
In Commercial Distribution

  • 00854427007988 ()
  • 85442700798802 ()


  • Surgical/examination garment kit

HEPRO.US Lab Suit - Case - 00854427007087

Material 43gsm A/S SMMS Color: Green - In Bulk, 50pcs/Ctn
HEPRO.US INC.
CT Lab Suit
In Commercial Distribution

  • 00854427007087 ()
  • 85442700708701 ()


  • Surgical/examination garment kit

Meniett™ Carrying Case - 05708265004980

No Description
Lina Medical ApS
MT-CASE
In Commercial Distribution

  • 05708265004980 ()
MT-CASE

  • Middle ear decompressor, positive pressure

DL handyscope Soft Case - 00850017651210

Protective soft case for DL handyscope, with lanyard
DermLite LLC
FFH2-1609
In Commercial Distribution

  • 00850017651210 ()
FFH2-1609

  • Dermatoscope, optical

HUMERAL NAIL CASE ASSEMBLY - 00848665040166

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9903-200
In Commercial Distribution

  • 00848665040166 ()


  • Instrument tray, reusable

LOWER EXTREMITY REAMER CASE - 00848665034257

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9918-100
In Commercial Distribution

  • 00848665034257 ()


  • Surgical instrument/implant rack

TROCHANTERIC IMPLANT CASE ASSEMBLY - 00848665024616

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9902-101
In Commercial Distribution

  • 00848665024616 ()


  • Instrument tray, reusable

TIBIAL NAIL Case Assembly - 00848665024463

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9904-001
In Commercial Distribution

  • 00848665024463 ()


  • Instrument tray, reusable

MODULAR IMPLANT Case ASSEMBLY - 00848665024432

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9901-101
In Commercial Distribution

  • 00848665024432 ()


  • Instrument tray, reusable

Lower Extremity Reamers Case - 00848665024173

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9918
In Commercial Distribution

  • 00848665024173 ()


  • Instrument tray, reusable

Humeral Nail Case Assembly - 00848665024098

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9903-100
In Commercial Distribution

  • 00848665024098 ()


  • Instrument tray, reusable

Modular Instrument Case Assembly - 00848665024074

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9901-100
In Commercial Distribution

  • 00848665024074 ()


  • Instrument tray, reusable

Echoport Case service kit - 05060396172762

Case (enclosure) service parts for Echoport
OTODYNAMICS LIMITED
EP-CASE-KIT
In Commercial Distribution

  • 05060396172762 ()


  • Otoacoustic emission system, line-powered

Otoport/Otocheck Carry Case - 05060396170454

No Description
OTODYNAMICS LIMITED
OP-CAS
In Commercial Distribution

  • 05060396170454 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

EXPERT LUX Case 680465LRN - EKAV100960480

No Description
KaVo Dental GmbH
1.009.6048
In Commercial Distribution

  • EKAV100960480 ()
680465LRN

  • Dental power tool system handpiece, pneumatic

SMART LUX Case 619460L - EKAV100957450

No Description
KaVo Dental GmbH
1.009.5745
In Commercial Distribution

  • EKAV100957450 ()
619460L

  • Dental power tool system handpiece, pneumatic

Baha 5 Inner Case - 09321502032803

No Description
Cochlear Bone Anchored Solutions AB
95224
In Commercial Distribution

  • 09321502032803 ()
95224

  • Bone-conduction hearing implant system sound processor/vibrator

Sugita Clip Metal Case - 04946329376289

Sugita Clip Metal Case A for Appliers
MIZUHO CORPORATION
07-936-66
In Commercial Distribution

  • 04946329376289 ()

  • Length: 514 Millimeter
07-936-66

  • Instrument transport trolley system

Sugita Titanium Clip Case - 04946329206579

Sugita Titanium Clip Case E for Extra Clips
MIZUHO CORPORATION
07-936-74
In Commercial Distribution

  • 04946329206579 ()

  • Length: 8.86 Inch
07-936-74

  • Surgical clip rack

Sugita Titanium Clip Case - 04946329206562

Sugita Titanium Clip Case D for Fenestrated Clips
MIZUHO CORPORATION
07-936-73
In Commercial Distribution

  • 04946329206562 ()

  • Length: 8.86 Inch
07-936-73

  • Surgical clip rack

Sugita Titanium Clip Case - 04946329206555

Sugita Titanium Clip Case C for Standard Clips
MIZUHO CORPORATION
07-936-72
In Commercial Distribution

  • 04946329206555 ()

  • Length: 8.86 Inch
07-936-72

  • Surgical clip rack

Sugita Titanium Clip Case - 04946329206548

Sugita Titanium Clip Case B for Mini, Standard and Temporary Clips
MIZUHO CORPORATION
07-936-71
In Commercial Distribution

  • 04946329206548 ()

  • Length: 8.86 Inch
07-936-71

  • Surgical clip rack

Case, 332×189×55.5mm - 04719886894035

No Description
UNITED ORTHOPEDIC CORP.
9901-8016
In Commercial Distribution

  • 04719886894035 ()
9901-8016

  • Instrument tray, reusable

MatrixPro Sterilization Case Lid - 00860540000218

No Description
PRO-DEX, INC.
60.000.011
In Commercial Distribution

  • 10860540000215 ()
  • 00860540000218 ()


  • Device sterilization/disinfection container, reusable

microTargeting™ Sterilization Case - 00873263003534

microTargeting Drive System WiSC Wash and Sterilization Case for automated washing systems
FHC, INC.
67-00-6-00353
In Commercial Distribution

  • 00873263001943 ()
  • 00873263003534 ()
67-00-6

  • Neurosurgical micro targeting drive

WayPoint™ Sterilization Case - 00873263003374

WayPoint Sterilization Case, 1x, nonsterile
FHC, INC.
66-WP-SC-00337
In Commercial Distribution

  • 00873263003374 ()
66-WP-SC

  • Surgical instrument/implant rack

ROSC-U Wheeled/Storage Case - 00860000876285

Case for storage/transport of ROSC-U, with wheels
RESUSCITATION INTERNATIONAL, LLC
A03-WB-000
In Commercial Distribution

  • 00860000876285 ()
A03-WB-000

  • Cardiac resuscitator, battery-powered

ROSC-U Carrying/Storage Case - 00860000876278

Case used for carrying and/or storage of ROSC-U
RESUSCITATION INTERNATIONAL, LLC
A03-PB-000
In Commercial Distribution

  • 00860000876278 ()
A03-PB-000

  • Cardiac resuscitator, battery-powered
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