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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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Jacobson Micro Needle Holder Diamond Dust™ jaw - 00846159005011

with ratchet straight jaw
SCANLAN INTERNATIONAL INC
6006-174
In Commercial Distribution

  • 00846159005011 ()
6006-174

  • Suturing needle holder, reusable

Jacobson Micro Needle Holder Diamond Dust™ jaw - 00846159005004

with ratchet straight jaw
SCANLAN INTERNATIONAL INC
6006-170
In Commercial Distribution

  • 00846159005004 ()
6006-170

  • Suturing needle holder, reusable

APEX - 04713025000080

XT Auto with Humidifier
Wellell Inc.
9S-005720, 9S-006500
In Commercial Distribution

  • 14713025000087 ()
  • 04713025000080 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000066

XT Prime with Humidifier
Wellell Inc.
9S-005580, 9S-006500
In Commercial Distribution

  • 14713025000063 ()
  • 04713025000066 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000042

XT Sense with Humidifier
Wellell Inc.
9S-005530, 9S-006500
In Commercial Distribution

  • 14713025000049 ()
  • 04713025000042 ()


  • Home CPAP unit
  • Heated respiratory humidifier

APEX - 04713025000028

XT Fit with Humidifier
Wellell Inc.
9S-005500, 9S-006500
In Commercial Distribution

  • 14713025000025 ()
  • 04713025000028 ()


  • Home CPAP unit
  • Heated respiratory humidifier

CARDINAL HEALTH - 10888439463835

CRANIOTOMY WITH BASIN PACK
Cardinal Health 200, LLC
SNE69CREC4
In Commercial Distribution

  • 50888439463833 ()
  • 10888439463835 ()
SNE69CREC4

  • Craniotomy kit

CARDINAL HEALTH - 10888439463477

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC5
In Commercial Distribution

  • 50888439463475 ()
  • 10888439463477 ()
SNE69LMEC5

  • Neurosurgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439746341

MINOR BASIN WITH GOWN
Cardinal Health 200, LLC
SBA22MBGC1
In Commercial Distribution

  • 50888439746349 ()
  • 10888439746341 ()
SBA22MBGC1

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439687323

SCOPE PACK WITH POUCH
Cardinal Health 200, LLC
SOP13SPBF1
In Commercial Distribution

  • 50888439687321 ()
  • 10888439687323 ()
SOP13SPBF1

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Affiniti - 00846832021598

T-HANDLE WITH HUDSON END
TORNIER, INC.
9000264
Not in Commercial Distribution

  • 00846832021598 ()
9000264

  • Surgical instrument handle, non-torque-limiting

Tissue-Tek® SmartWrite® - 00615233082374

Cassette Printer with AutoLoader
SAKURA FINETEK U.S.A., INC.
9020
In Commercial Distribution

  • 00615233082374 ()
9020

  • Cell morphology analyser IVD, automated/semi-automated
  • Computed radiography digital imaging scanner

ALLEN - 00615521012816

SHOULDER SUPPORTS WITH PADS
HILL-ROM, INC.
102009
In Commercial Distribution

  • 00615521012816 ()
F-63500

  • Operating table torso positioner

CARDINAL HEALTH - 10888439584073

KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401325
In Commercial Distribution

  • 50888439584071 ()
  • 10888439584073 ()
OMS4401325

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439523973

KNEE WITH ACL RECONSTRUCTION
Cardinal Health 200, LLC
SOP34ARKS1
In Commercial Distribution

  • 50888439523971 ()
  • 10888439523973 ()
SOP34ARKS1

  • Orthopaedic surgical procedure kit, non-medicated, single-use

Elemax® Cortical Cancellous Spacer - 00846468062712

Inserter Shaft with Stop
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT-S
Not in Commercial Distribution

  • 00846468062712 ()


  • General internal orthopaedic fixation system implantation kit

CARDINAL HEALTH - 10888439529838

CATARACT WITH TUBING PACK
Cardinal Health 200, LLC
SEY44CAASC
In Commercial Distribution

  • 50888439529836 ()
  • 10888439529838 ()
SEY44CAASC

  • Ophthalmic surgical procedure kit, medicated, single-use

NA - 10190886103623

KEY CHAIN WITH D-TIES
G & H Wire Company, Inc.
DTKEYCH
In Commercial Distribution

  • 10190886103623 ()


  • Orthodontic archwire/bracket ligature

Calix Spinal Implant System - M697X00300151

Inserter Assembly, with Stop
Xtant Medical Holdings, Inc.
X003-0015
In Commercial Distribution

  • M697X00300150 ()
  • M697X00300151 ()


  • Polymeric spinal interbody fusion cage

Ceramco® 3 - D0013016050

With Powder Opaque Kit
Dentsply International Inc.
16 Shade Basic System
Not in Commercial Distribution

  • D0013016050 ()
301605

  • Dental appliance fabrication material, ceramic

Ceramco® 3 - D0013016040

With Paste Opaque Kit
Dentsply International Inc.
16 Shade Basic System
Not in Commercial Distribution

  • D0013016040 ()
301604

  • Dental appliance fabrication material, ceramic

Ceramco® 3 - D0013016030

With Powder Opaque Kit
Dentsply International Inc.
8 Shade Mini System
Not in Commercial Distribution

  • D0013016030 ()
301603

  • Dental appliance fabrication material, ceramic

Ceramco® 3 - D0013016020

With Paste Opaque Kit
Dentsply International Inc.
8 Shade Mini System
Not in Commercial Distribution

  • D0013016020 ()
301602

  • Dental appliance fabrication material, ceramic

Natus® - 00382830056861

Pudenz Catheter with Stylet
NATUS MEDICAL INCORPORATED
NT8501228
In Commercial Distribution


  • Tubing: 1.3mm I.D. x 2.5mm O.D.; Total Length: 18cm (7") (all dimensions nominal)
NT8501228

  • Intracerebral infusion/drainage catheter, long-term

Natus - 00382830056335

RetCam Envision with FA
XLTEK
61-000300
In Commercial Distribution

  • 00382830056335 ()


  • Ophthalmic fundus camera

Alamo C - M6861412T400S0

Inserter with Stop Instrument
ALLIANCE PARTNERS LLC
1412T-400-S
In Commercial Distribution

  • M6861412T400S0 ()
1412T-400-S

  • Orthopaedic inorganic implant inserter/extractor, reusable

Innospire Elegance - 00383730004112

ELEGANCE WITH SSR (RUSSIA)
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730004112 ()
1103294

  • Benchtop nebulizer, non-heated

Medline - 10888277588837

MONTHLY KIT WITH TEGADERM
MEDLINE INDUSTRIES, INC.
DYKM1102
In Commercial Distribution

  • 10888277588837 ()
DYKM1102

  • Medical device disinfection agent

Medline Industries, Inc. - 10888277540057

CATARACT PACK (WITH PHACO)
MEDLINE INDUSTRIES, INC.
DYNJ47170A
In Commercial Distribution

  • 10888277540057 ()
DYNJ47170A

  • General surgical procedure kit, non-medicated, reusable

CARDINAL HEALTH - 10888439092363

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMEC1
In Commercial Distribution

  • 50888439092361 ()
  • 10888439092363 ()
SNE69LMEC1

  • Neurosurgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439081206

LAMINECTOMY WITH BASIN PK
Cardinal Health 200, LLC
SNE69LMECG
In Commercial Distribution

  • 50888439081204 ()
  • 10888439081206 ()
SNE69LMECG

  • Neurosurgical procedure kit, non-medicated, single-use

MedStream - 00842472106725

DRESSING CHANGE WITH GRIPLOK
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
MSDC-021241
In Commercial Distribution

  • 10842472106272 ()
  • 00842472106725 ()
MSDC-021241

  • Vascular catheterization support/maintenance kit, non-medicated

MedStream - 00842472106718

DRESSING CHANGE WITH GRIPLOK
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
MSDC-021240
In Commercial Distribution

  • 10842472106715 ()
  • 00842472106718 ()
MSDC-021240

  • Vascular catheterization support/maintenance kit, non-medicated

Wiener antrum rasp - 04250676710185

with trocar 19.5 cm
Spiggle & Theis Medizintechnik GmbH
30-818-20
In Commercial Distribution

  • 04250676710185 ()
30-818-20

  • Nasal file/rasp

ManoScan - 04260167482491

ESO With Extended Tip
Given Imaging, Inc.
RFG-8000-15
In Commercial Distribution

  • 04260167482491 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482439

ESO With Extended Tip
Given Imaging, Inc.
800015
In Commercial Distribution

  • 04260167482439 ()


  • Manometric gastrointestinal motility analysis system

BMT Medizintechnik GmbH - 04251725217815

VIAL SYRINGE WITH ASPIRATOR
BMT Medizintechnik GmbH
STF-1
In Commercial Distribution

  • 04251725217815 ()
STF-1

  • Dental anaesthesia syringe, reusable

NA - 04250869692007

Tray with lid 135x120x47mm
Biedermann Motech GmbH & Co. KG
207-050-0525
In Commercial Distribution

  • 04250869692007 ()
207-050-0525

  • General internal orthopaedic fixation system implantation kit

NA - 04250869691826

Tray with lid 267x125x49mm
Biedermann Motech GmbH & Co. KG
208-050-0523
In Commercial Distribution

  • 04250869691826 ()
208-050-0523

  • General internal orthopaedic fixation system implantation kit

NA - 04250869691819

Tray with lid 273x84x41mm
Biedermann Motech GmbH & Co. KG
208-050-0522
In Commercial Distribution

  • 04250869691819 ()
208-050-0522

  • General internal orthopaedic fixation system implantation kit
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