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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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SurgiCase Online - E314SURGICASEONLINE0

SurgiCase Online
Materialise NV
SurgiCase Online
In Commercial Distribution

  • E314SURGICASEONLINE0 ()
SurgiCase Online

  • CAD/CAM software

PDT, Inc. - 00813677021151

Montana Explorer
PDT, INC.
R170 Montana Explorer
In Commercial Distribution

  • 00813677021151 ()
R170

  • Dental surgical probe, reusable

ProPlan CMF - E314PROPLANCMFONLINE0

ProPlan CMF Online
Materialise NV
ProPlan CMF Online
In Commercial Distribution

  • E314PROPLANCMFONLINE0 ()
ProPlan CMF Online

  • CAD/CAM software

CARDINAL HEALTH - 10887488660851

STERILE MONTANA PACK
Cardinal Health 200, LLC
SEYCNCDPEB
In Commercial Distribution

  • 50887488660859 ()
  • 10887488660851 ()
SEYCNCDPEB

  • Ophthalmic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488785820

STERILE MONTANA PACK
Cardinal Health 200, LLC
SEYCNCDPEC
In Commercial Distribution

  • 50887488785828 ()
  • 10887488785820 ()
SEYCNCDPEC

  • Ophthalmic surgical procedure kit, medicated, single-use

PDT, Inc. - 00813677020017

Montana Jack Scaler
PDT, INC.
R138 Montana Jack Scaler
In Commercial Distribution

  • 00813677020017 ()
R138

  • Manual dental scaler, reusable

Zimmer - E314ZIMMERPSIOMS0

Zimmer online management system
Materialise NV
Zimmer online management system
Not in Commercial Distribution

  • E314ZIMMERPSIOMS0 ()
Zimmer online management system

  • CAD/CAM software

Signature - E314SIGNATUREOMS0

Signature online management system
Materialise NV
Signature online management system
Not in Commercial Distribution

  • E314SIGNATUREOMS0 ()
Signature online management system

  • CAD/CAM software

PDT, Inc. - 00813677025241

R218 Montana Precision Probe
PDT, INC.
R218 Montana Precision Probe
In Commercial Distribution

  • 00813677025241 ()
R218

  • Dental surgical probe, reusable

PDT, Inc. - 00813677020956

Montana Jack Blunt Titanium
PDT, INC.
R138T Montana Jack Blunt Titanium
In Commercial Distribution

  • 00813677020956 ()
R138T

  • Manual dental scaler, reusable

PDT, Inc. - 00813677020000

Montana Jack Scaler Rigid
PDT, INC.
R138R Montana Jack Scaler Rigid
In Commercial Distribution

  • 00813677020000 ()
R138R

  • Manual dental scaler, reusable

10PW - Montana Body Fluid - 00766588180014

10PW - Montana Body Fluid
Certified Safety Manufacturing, Inc.
FK418-001
In Commercial Distribution

  • 00766588180014 ()
FK418-001

  • First aid kit, medicated

10M - Montana Body Fluid - 00766588189031

10M - Montana Body Fluid
Certified Safety Manufacturing, Inc.
FK418-003
In Commercial Distribution

  • 00766588189031 ()
FK418-003

  • First aid kit, medicated

Montana BFK - 10 Refill - 00766588189017

Montana BFK - 10 Refill
Certified Safety Manufacturing, Inc.
FKR418-001
In Commercial Distribution

  • 00766588189017 ()
FKR418-001

  • First aid kit, medicated

Lexie Hearing - 00850022464171

Lexie Lumen Duo Silver - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Silver
In Commercial Distribution

  • 00850022464171 ()
LLO00004SL

  • Air-conduction hearing aid, receiver-in-canal

Lexie Hearing - 00860003469866

Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution

  • 00860003469866 ()
LLO00002BR

  • Air-conduction hearing aid, receiver-in-canal

I-neb - 00383730001005

I-neb Insight Online Multi-Lang Assembly
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
Not in Commercial Distribution

  • 00383730001005 ()
1100081

  • Ultrasonic nebulizing system

Go Prime - 00810153660040

Go Prime - Black - WAG Online
HEARX GROUP (PTY) LTD
Go Hearing
Not in Commercial Distribution

  • 00810153660040 ()
GHPS00003BL

  • Air-conduction hearing aid, in-the-ear

PDT, Inc. - 00813677024329

R138C Montana Jack (COMPLIMENTARY, PROMO)
PDT, INC.
R138C Montana Jack
In Commercial Distribution

  • 00813677024329 ()
R138C

  • Manual dental scaler, reusable

PDT, Inc. - 00813677020949

PDT Montana Jack Scaler BC
PDT, INC.
R138BC PDT Montana Jack Scaler BC
In Commercial Distribution

  • 00813677020949 ()
R138BC

  • Manual dental scaler, reusable

Lexie B1, Powered by Bose - 00850022464492

Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
LB1001
In Commercial Distribution

Online

  • Air-conduction hearing aid, receiver-in-canal

Lexie Hearing - 00860003469880

Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution

  • 00860003469880 ()
LLO00002MB

  • Air-conduction hearing aid, receiver-in-canal

Lexie Hearing - 00860003469842

Lexie Lumen Duo Light Gray - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Light Gray
In Commercial Distribution

  • 00860003469842 ()
LLO00002GR

  • Air-conduction hearing aid, receiver-in-canal

Alcon - 00380659909498

Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software

PDT, Inc. - 00813677025197

R138-25 25th Anniversary Montana Jack®
PDT, INC.
R138-25 25th Anniversary Montana Jack®
In Commercial Distribution

  • 00813677025197 ()
R138-25

  • Manual dental scaler, reusable

Brasseler USA - 00887919737896

MONTANA VA C & B QUICKIT 1P
Peter Brasseler Holdings, LLC
5024937U0
In Commercial Distribution

  • 00887919737896 ()


  • Diamond dental bur, single-use

Lexie Hearing - 00850022464157

Lexie Lumen OTC Hearing Aids - Beige Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Beige
In Commercial Distribution

  • 00850022464157 ()
LLO00003BE

  • Air-conduction hearing aid, receiver-in-canal

Lexie Hearing - 00850022464065

Lexie Lumen OTC Hearing Aids - Gray Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Gray
In Commercial Distribution

  • 00850022464065 ()
LLO00001GR

  • Air-conduction hearing aid, receiver-in-canal

Lexie B2 Plus Powered by Bose - 00810153660033

Lexie B2 Plus Powered by Bose-WAG Online
HEARX GROUP (PTY) LTD
Lexie Hearing
In Commercial Distribution

  • 00810153660033 ()
LBS00002B2PLS

  • Air-conduction hearing aid, receiver-in-canal

PDT, Inc. - 00813677024350

R138BCR Montana Jack® Rigid Scaler Pink
PDT, INC.
R138BCR
In Commercial Distribution

  • 00813677024350 ()


  • Manual dental scaler, reusable

Go Hearing - 00810153660057

Go Hearing - Go Ultra - Gray - BTE - WAG Online
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online
In Commercial Distribution

  • 00810153660057 ()


  • Air-conduction hearing aid, behind-the-ear

A Plus - 00683534080566

Basin wrap 50"x76" 2.25m;on-line lam, 1170pc/glrd
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080562 ()
  • 00683534080566 ()
BW50076-1

  • Medical equipment/instrument drape, single-use

A Plus - 00683534080559

Basin wrap 50"x50" 2.25m;on-line lam,1800pc/G
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534080555 ()
  • 00683534080559 ()
BW50050-1

  • Medical equipment/instrument drape, single-use

Go Hearing - 10810153660054

Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE
HEARX GROUP (PTY) LTD
Go Ultra - Gray - BTE - WAG Online - CASE
In Commercial Distribution

  • 10810153660054 ()
GHUS00002CA

  • Air-conduction hearing aid, behind-the-ear

HPLC Column - 04250317523822

HPLC Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38910
In Commercial Distribution

  • 04250317523822 ()

  • 1 pcs.
38910

  • High performance liquid chromatography analyser column IVD

Trap Column - 04250317523761

Trap Column, Online Method, 25-OH-Vitamin D3/D2 in serum/plasma
Chromsystems Instruments + Chemicals GmbH
38920
In Commercial Distribution

  • 04250317523761 ()

  • 1 pcs.
38920

  • High performance liquid chromatography analyser column IVD

ONLINE TDM Phenobarbital - 04015630997060

No Description
Roche Diagnostics GmbH
3510620190
Not in Commercial Distribution

  • 04015630997060 ()
3510620190

  • Phenobarbital therapeutic drug monitoring IVD, kit, fluorescent immunoassay

ONLINE TDM Lidocaine - 04015630996933

No Description
Roche Diagnostics GmbH
3376222190
Not in Commercial Distribution

  • 04015630996933 ()
3376222190

  • Lidocaine therapeutic drug monitoring IVD, reagent

ONLINE TDM Theophylline - 04015630997169

No Description
Roche Diagnostics GmbH
3531066190
Not in Commercial Distribution

  • 04015630997169 ()
3531066190

  • Theophylline therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ONLINE TDM Phenytoin - 04015630997138

No Description
Roche Diagnostics GmbH
3516989190
Not in Commercial Distribution

  • 04015630997138 ()
3516989190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
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