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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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Virage® - 00889024328808

No Description
BIOMET SPINE LLC
07.01719.001
In Commercial Distribution

  • 00889024328808 ()

  • Closure Top, Head to Head Transverse Connector
07.01719.001

  • Bone-screw internal spinal fixation system, non-sterile

BARD® BURBANK - 00801741090233

BARD® BURBANK™ Carotid Bypass Shunt, 18F - 12F x 15.5cm
Bard Peripheral Vascular, Inc.
SGA162001
Not in Commercial Distribution

  • 10801741090230 ()
  • 00801741090233 ()

  • Length: 15.5 Centimeter
  • External Diameter - 18 French to 12 French
SGA162001

  • Carotid artery shunt

BARD® JAVID - 00801741090226

BARD® JAVID™ Carotid Bypass Shunt, 14F - 8F x 13cm
Bard Peripheral Vascular, Inc.
SGA155001
Not in Commercial Distribution

  • 10801741090223 ()
  • 00801741090226 ()

  • Length: 13 Centimeter
  • External Diameter - 14 French to 8 French
SGA155001

  • Carotid artery shunt

BARD® BURBANK - 00801741090219

BARD® BURBANK™ Carotid Bypass Shunt, 12F - 9F x 15.5cm
Bard Peripheral Vascular, Inc.
SGA150001
Not in Commercial Distribution

  • 10801741090216 ()
  • 00801741090219 ()

  • Length: 15.5 Centimeter
  • External Diameter - 12 French to 9 French
SGA150001

  • Carotid artery shunt

BARD® BURBANK - 00801741090202

BARD® BURBANK™ Carotid Bypass Shunt, 15F - 10F x 15.5cm
Bard Peripheral Vascular, Inc.
SGA149001
Not in Commercial Distribution

  • 10801741090209 ()
  • 00801741090202 ()

  • Length: 15.5 Centimeter
  • External Diameter - 15 French to 10 French
SGA149001

  • Carotid artery shunt

BARD® BRENER - 00801741090196

BARD® BRENER™ Carotid Bypass Shunt, Tapered Carotid Shunt With Side Arm, 17F - 10F x 13cm
Bard Peripheral Vascular, Inc.
S11887002
Not in Commercial Distribution

  • 10801741090193 ()
  • 00801741090196 ()

  • External Diameter - 17 French to 10 French
  • Length: 13 Centimeter
S11887002

  • Carotid artery shunt

BARD® BRENER - 00801741090127

BARD® BRENER™ Carotid Bypass Shunt, Tapered Carotid Shunt With Side Arm, 14F-8F x 13cm
Bard Peripheral Vascular, Inc.
007755
Not in Commercial Distribution

  • 10801741090124 ()
  • 00801741090127 ()

  • External Diameter - 14 French to 8 French
  • Length: 13 Centimeter
007755

  • Carotid artery shunt

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

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 - 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 - 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 - 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

PRO OSTEON 500R - 00888480585015

Resorbable Bone Graft Substitute
Biomet Orthopedics, LLC
5RG30L
In Commercial Distribution

  • 00888480585015 ()

  • Large Granules (5mm to 9mm Ø) 30cc
5RG30L

  • Bone matrix implant, synthetic, non-antimicrobial

PRO OSTEON 500R - 00888480584988

Resorbable Bone Graft Substitute
Biomet Orthopedics, LLC
5RG15L
In Commercial Distribution

  • 00888480584988 ()

  • Large Granules (5mm to 9mm Ø) 15cc
5RG15L

  • Bone matrix implant, synthetic, non-antimicrobial

VAIL OCT SPINAL FIXATION SYSTEM - 00888480548362

No Description
BIOMET SPINE LLC
7904-4032
In Commercial Distribution

  • 00888480548362 ()

  • ROD CONNECTOR TI Ø3.5 TO 2XØ5.5MM WIDE
7904-4032

  • Bone-screw internal spinal fixation system, non-sterile

VAIL OCT SPINAL FIXATION SYSTEM - 00888480548348

No Description
BIOMET SPINE LLC
7904-4022
In Commercial Distribution

  • 00888480548348 ()

  • ROD CONNECTOR TI Ø3.5 TO Ø5.5MM WIDE
7904-4022

  • Bone-screw internal spinal fixation system, non-sterile

VAIL OCT SPINAL FIXATION SYSTEM - 00888480548324

No Description
BIOMET SPINE LLC
7904-3012
In Commercial Distribution

  • 00888480548324 ()

  • ROD CONNECTOR TI Ø3.5 TO Ø3.5MM WIDE
7904-3012

  • Bone-screw internal spinal fixation system, non-sterile

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

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

Hearing Help Express - 00858177007113

iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software

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

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

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

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

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

DreamMapper - 00606959057982

DreamMapper Web (EMEA)
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959057982 ()
1128262

  • Self-care monitoring/reporting software

DreamMapper - 00606959057623

DreamMapper Web (EMEA)
Respironics, Inc.
DreamMapper Web EMEA - 2
In Commercial Distribution

  • 00606959057623 ()
1128262

  • Self-care monitoring/reporting software

DreamMapper - 00606959057616

DreamMapper Web (DM)
Respironics, Inc.
DreamMapper Web Software, North America Instance - 2
In Commercial Distribution

  • 00606959057616 ()
1101679

  • Self-care monitoring/reporting software

EncorePro2 - 00606959053786

EncorePro2 Software (Web)
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959053786 ()
1099731

  • Medical equipment clinical data interfacing software

DreamMapper Web (EMEA) - 00606959048515

DreamMapper Web (EMEA)
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959048515 ()
1128262

  • Self-care monitoring/reporting software
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