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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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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

NA - 04250869691796

Tray with lid 145x44x25mm
Biedermann Motech GmbH & Co. KG
113438
In Commercial Distribution

  • 04250869691796 ()
113438

  • General internal orthopaedic fixation system implantation kit

CARDINAL HEALTH - 10888439006506

KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401323
In Commercial Distribution

  • 50888439006504 ()
  • 10888439006506 ()
OMS4401323

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

FENTEX - 04250407778378

Handle with suction control
FENTEX medical GmbH
270025FX
In Commercial Distribution

  • 04250407778378 ()
270025FX

  • Ear canal suction handle

Dentronix - D661D139C0

BIRD BEAK WITH CUTTER
COLTENE/WHALEDENT INC
D139C
Not in Commercial Distribution

  • D661D139C0 ()


  • Orthodontic pliers

Medline Industries, Inc. - 10888277519855

CVAD WITH PVP KIT
MEDLINE INDUSTRIES, INC.
DYNDC1976B
In Commercial Distribution

  • 10888277519855 ()
DYNDC1976B

  • General surgical procedure kit, non-medicated, reusable

CARDINAL HEALTH - 10887488911182

KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401321
In Commercial Distribution

  • 50887488911180 ()
  • 10887488911182 ()
OMS4401321

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

Gingivamoll - 00842092112328

Gingivamoll Model with Mask
Preat Corporation
0900003
Not in Commercial Distribution

  • 00842092112328 ()
0900003

  • Dental acrylic resin kit

CARDINAL HEALTH - 10887488921990

KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401322
In Commercial Distribution

  • 50887488921998 ()
  • 10887488921990 ()
OMS4401322

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

Medline Industries, Inc. - 10888277082939

BASIN PACK WITH GOWNS
MEDLINE INDUSTRIES, INC.
DYNJ44070
In Commercial Distribution

  • 10888277082939 ()
DYNJ44070

  • General surgical procedure kit, non-medicated, reusable

Preparation tray, stainless steel - 04250381850169

with scale, 92x54 mm
Spiggle & Theis Medizintechnik GmbH
10-735-00
In Commercial Distribution

  • 04250381850169 ()
10-735-00

  • Surgical cutting/shaping board, reusable

NA - 00841983103186

PATIENT MONITOR, with RECORDER
NIHON KOHDEN AMERICA, INC.
BSM-4104A
In Commercial Distribution

  • 00841983103186 ()
BSM-4104A

  • Centralized patient monitor

Mammotome - 00841911100607

Control Module with SmartVac
DEVICOR MEDICAL PRODUCTS, INC.
SCM23
In Commercial Distribution

  • 00841911100607 ()
SCM23

  • Mammographic stereotactic biopsy system

Mammotome - 00841911100591

Control Module with SmartVac
DEVICOR MEDICAL PRODUCTS, INC.
SCM12
In Commercial Distribution

  • 00841911100591 ()
SCM12

  • Mammographic stereotactic biopsy system

CARDINAL HEALTH - 10887488775111

STERILE ANGIOPLASTY WITH STENT
Cardinal Health 200, LLC
SCV41APPDH
In Commercial Distribution

  • 50887488775119 ()
  • 10887488775111 ()
SCV41APPDH

  • Angiography kit

Miracle Suction FULL Kit - 08806383524490

Multifunctional Mirror with Suction
DiaDent Group International
Cleaning Brush
In Commercial Distribution

  • 08806383524490 ()
901-501

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524452

Multifunctional Mirror with Suction
DiaDent Group International
Silicone Hose
In Commercial Distribution

  • 08806383524452 ()
901-302

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524445

Multifunctional Mirror with Suction
DiaDent Group International
,Silicone Handle
In Commercial Distribution

  • 08806383524445 ()
901-301

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524438

Multifunctional Mirror with Suction
DiaDent Group International
HEAD_6ea
In Commercial Distribution

  • 08806383524438 ()
901-202

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524421

Multifunctional Mirror with Suction
DiaDent Group International
HEAD_1ea
In Commercial Distribution

  • 08806383524421 ()
901-201

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524414

Multifunctional Mirror with Suction
DiaDent Group International
GREY
In Commercial Distribution

  • 08806383524414 ()
901-105

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524407

Multifunctional Mirror with Suction
DiaDent Group International
GREEN
In Commercial Distribution

  • 08806383524407 ()
901-104

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524391

Multifunctional Mirror with Suction
DiaDent Group International
RED
In Commercial Distribution

  • 08806383524391 ()
901-103

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524384

Multifunctional Mirror with Suction
DiaDent Group International
BLUE
In Commercial Distribution

  • 08806383524384 ()
901-102

  • Dental mirror, reusable

MIRACLE SUCTION,MINI KIT - 08806383524346

Multifunctional Mirror with Suction
DiaDent Group International
MINI KIT
In Commercial Distribution

  • 08806383524346 ()
901-002

  • Dental mirror, reusable

Miracle Suction FULL Kit - 08806383524339

Multifunctional Mirror with Suction
DiaDent Group International
FULL KIT
In Commercial Distribution

  • 08806383524339 ()
901-001

  • Dental mirror, reusable

NOVO Health Services, LLC - 00812564034403

BASIN SET WITH GOWNS
NOVO HEALTH SERVICES, LLC
124967
Not in Commercial Distribution

  • 00812564034403 ()

  • Weight: 7.2 Pound
  • Width: 14 Inch
  • Height: 9.5 Inch
124967B

  • General surgical procedure kit, non-medicated, reusable

NOVO Health Services, LLC - 00812564034281

BASIN SET WITH GOWNS
NOVO HEALTH SERVICES, LLC
124967
Not in Commercial Distribution

  • 00812564034281 ()

  • Height: 9.5 Inch
  • Width: 14 Inch
  • Weight: 7.2 Pound
124967A

  • General surgical procedure kit, non-medicated, reusable

NA - 07613153057765

Screw Rack with Lid
Stryker GmbH
901686
In Commercial Distribution

  • 07613153057765 ()
901686

  • Surgical instrument/implant rack

MATTA - PELVIC - 07613153057741

Plate Rack with Lid
Stryker GmbH
901684
In Commercial Distribution

  • 07613153057741 ()
901684

  • Surgical instrument/implant rack

MATTA - PELVIC - 07613153057734

Plate Rack with Lid
Stryker GmbH
901683
In Commercial Distribution

  • 07613153057734 ()
901683

  • Surgical instrument/implant rack
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