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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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TUBE SHAFT INSULATED - B09929011090

TUBE SHAFT INSULATED WITHOUT LUER LOCK
SONTEC INSTRUMENTS, INC.
2901-109
Not in Commercial Distribution

  • B09929011090 ()

  • Length: 450 Millimeter
  • Insulation reduction to 5mm Shaft
  • 10mm Shaft


  • Laparoscopic surgical procedure kit, non-medicated, reusable

TUBE SHAFT INSULATED - B0992901105L0

TUBE SHAFT INSULATED WITH LUER LOCK
SONTEC INSTRUMENTS, INC.
2901-105L
Not in Commercial Distribution

  • B0992901105L0 ()

  • Length: 330 Millimeter
  • Insulation reduction to 5mm Shaft
  • 10mm Shaft


  • Laparoscopic surgical procedure kit, non-medicated, reusable

TUBE SHAFT INSULATED - B0992901109L0

TUBE SHAFT INSULATED WITH LUER LOCK
SONTEC INSTRUMENTS, INC.
2901-109L
Not in Commercial Distribution

  • B0992901109L0 ()

  • Length: 450 Millimeter
  • Insulation reduction to 5mm Shaft
  • 10mm Shaft


  • Laparoscopic surgical procedure kit, non-medicated, reusable

TUBE SHAFT INSULATED - B0992901107L0

TUBE SHAFT INSULATED WITH LUER LOCK
SONTEC INSTRUMENTS, INC.
2901-107L
Not in Commercial Distribution

  • B0992901107L0 ()

  • Insulation reduction to 5mm Shaft
  • Length: 360 Millimeter
  • 10mm Shaft


  • Laparoscopic surgical procedure kit, non-medicated, reusable

TUBE SHAFT INSULATED - B09929011070

TUBE SHAFT INSULATED WITHOUT LUER LOCK
SONTEC INSTRUMENTS, INC.
2901-107
Not in Commercial Distribution

  • B09929011070 ()

  • Length: 360 Millimeter
  • Insulation reduction to 5mm Shaft
  • 10mm Shaft


  • Laparoscopic surgical procedure kit, non-medicated, reusable

TUBE SHAFT INSULATED - B09929011050

TUBE SHAFT INSULATED WITHOUT LUER LOCK
SONTEC INSTRUMENTS, INC.
2901-105
Not in Commercial Distribution

  • B09929011050 ()

  • Length: 330 Millimeter
  • Insulation reduction to 5mm Shaft
  • 10mm Shaft


  • Laparoscopic surgical procedure kit, non-medicated, reusable

Phoenix - 44900719317021

No Description
DR.JAPAN CO., LTD.
PP2227G500-INT
In Commercial Distribution

  • 44900719317021 ()
  • 04900719317023 ()

  • Length: 5 Inch
  • Tapers from 22 Gauge to 27 Gauge


  • Spinal needle, single-use

Phoenix - 44900719317014

No Description
DR.JAPAN CO., LTD.
PP2225G500-INT
In Commercial Distribution

  • 44900719317014 ()
  • 04900719317016 ()

  • Length: 5 Inch
  • Tapers from 22 Gauge to 25 Gauge


  • Spinal needle, single-use

BARD® JAVID - 00801741090110

BARD® JAVID™ Carotid Bypass Shunt, 17F - 10F x 27.5cm
Bard Peripheral Vascular, Inc.
007714
Not in Commercial Distribution

  • 10801741090117 ()
  • 00801741090110 ()

  • External Diameter - 17 French to 10 French
  • Length: 27.5 Centimeter
007714

  • Carotid artery shunt

PursueCare RESET-O - 00850074433026

RESET-O is an Android application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as a adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433026 ()


  • Mental health/function therapeutic software, screen-viewed

Young - 00302731313207

Young DPA Classic Traditional Web, Firm, Long, White Web Cup
YOUNG DENTAL MANUFACTURING I, LLC
131320
Not in Commercial Distribution

  • 10302731313204 ()
  • 00302731313207 ()
  • 20302731313201 ()
131320

  • Dental polishing cup, single-use

ASSURE Patient Application - 00840241600214

ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software

Hearing Help Express - 00858177007113

iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software

Rexton - 05714880113204

APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control

AudioService - 05714880113198

APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control

myRemote - 05714880113181

APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control

Vibe - 05714880113174

APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control

Signia - 05714880113167

APP SIGNIA
Ws Audiology Usa, Inc.
Signia App
In Commercial Distribution

  • 05714880113167 ()
10996563

  • Hearing aid/implant system remote control

TruHearing - 05714880113150

APP TRUHEARING
Ws Audiology Usa, Inc.
TruHearing App
In Commercial Distribution

  • 05714880113150 ()
10996369

  • Hearing aid/implant system remote control

audifon - EADF03410600217207189

audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.3
In Commercial Distribution

  • EADF03410600217207189 ()
03410600217207189

  • Hearing aid wireless-fitting computer-aided set

audifon - EADF034106002172068681

audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.2
In Commercial Distribution

  • EADF034106002172068681 ()
03410600217206868

  • Hearing aid wireless-fitting computer-aided set

Sonova - 07613389310979

myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software

Phonak - 07613389082623

myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software

PRC - 00816486021060

Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer

Accu-Beam - B1778194101070

Kit to convert 8102 to 8194107.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-07
In Commercial Distribution

  • B1778194101070 ()


  • Surgical camera holder

Accu-Beam - B1778194101050

Kit to convert 8102 to 8194105.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-05
In Commercial Distribution

  • B1778194101050 ()


  • Surgical camera holder

Accu-Beam - B1778194101030

Kit to convert 8102 to 8194103.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-03
In Commercial Distribution

  • B1778194101030 ()


  • Surgical camera holder

Accu-Beam - B1778194101020

Kit to convert 8102 to 8194102.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-02
In Commercial Distribution

  • B1778194101020 ()


  • Surgical camera holder

Accu-Beam - B1778194101010

Kit to convert 8102 to 8194101.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-01
In Commercial Distribution

  • B1778194101010 ()


  • Surgical camera holder

MediByte CPAP Adapter - B14085520

Tubing to connect CPAP to MediByte.
Braebon Medical Corporation
8552
In Commercial Distribution

  • B14085520 ()
8552

  • Gas-sampling/monitoring respiratory tubing, single-use

Accu-Beam - B1778194101M010

Kit to convert 8102 to 8194101M.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101M-01
In Commercial Distribution

  • B1778194101M010 ()


  • Surgical camera holder

Accu-Beam - B1778194101090

Kit to convert 8102 to 8194109.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-09
In Commercial Distribution

  • B1778194101090 ()


  • Surgical camera holder

Accu-Beam - B1778194101060

Kit to convert 8102 to 8194106.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-06
In Commercial Distribution

  • B1778194101060 ()


  • Surgical camera holder

Accu-Beam - B1778194101040

Kit to convert 8102 to 8194104.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8194101-04
In Commercial Distribution

  • B1778194101040 ()


  • Surgical camera holder

Medline Industries, Inc. - 10889942482801

MICRO PUNCTURE 4FR REG NT/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST03A
In Commercial Distribution

  • 40889942482802 ()
  • 10889942482801 ()
DYNJMAST03A

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

Synchron - 15099590233228

Triglycerides Reagent (TG 2 x 300)
Beckman Coulter, Inc.
445850
In Commercial Distribution

  • 15099590233228 ()
445850

  • Triglyceride IVD, kit, spectrophotometry

HU-FRIEDY - 10889950022563

#13K/TG DE Curette/Chisel #9Hdl
HU-FRIEDY MFG. CO., LLC
S13K/TG9
In Commercial Distribution

  • 10889950022563 ()
S13K/TG9

  • Periodontal file/rasp, manual

IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab) - 00630414962115

TG Ab - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381655
In Commercial Distribution

  • 00630414962115 ()
L2KTG6

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab) - 00630414962108

TG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381659
In Commercial Distribution

  • 00630414962108 ()
L2KTG2

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

IMMULITE/IMMULITE 1000 Systems ATG Anti-TG Ab - 00630414964676

TG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381641
Not in Commercial Distribution

  • 00630414964676 ()
LKTG1

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
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