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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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Children's Battery Pack blue 27 cm - 09008737039387

Audio Processor Battery Pack
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
03938
In Commercial Distribution

  • 09008737039387 ()


  • Cochlear implant/auditory brainstem implant battery

Children's Battery Pack grey 27 cm - 09008737039370

Audio Processor Battery Pack
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
03937
In Commercial Distribution

  • 09008737039370 ()


  • Cochlear implant/auditory brainstem implant battery

Children's Battery Pack anthracite 27 cm - 09008737024215

Audio Processor Battery Pack
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
02421
In Commercial Distribution

  • 09008737024215 ()


  • Cochlear implant/auditory brainstem implant battery

Facilis™ Spinal System - 04718251506122

Facilis™ Spinal System Smooth Rod: 5.5*90
BAUI BIOTECH CO. LTD.
320-5509
In Commercial Distribution

  • 04718251506122 ()


  • Bone-screw internal spinal fixation system rod

TREND II Spinal Fixation System- STEP Series - 04712832360349

Smooth Rod, D 5.50 x L 90 mm
Paonan Biotech Co.,Ltd.
1600-5509
In Commercial Distribution

  • 04712832360349 ()

  • Length: 90 Millimeter
  • Outer Diameter: 5.50 Millimeter
1600-5509

  • Bone-screw internal spinal fixation system rod

neon™ superior spine system - 04052536003310

neon rod, Ø 4.5 mm, length 90 mm
Ulrich GmbH & Co. KG
CS 1408-90T
In Commercial Distribution

  • 04052536003310 ()
CS 1408-90T

  • Bone-screw internal spinal fixation system rod

flamenco™ spinal fixation system - 04052536021420

flamenco rod, ø 5.5 mm, length 90 mm
Ulrich GmbH & Co. KG
CS 8012-090
Not in Commercial Distribution

  • 04052536021420 ()
CS 8012-090

  • Bone-screw internal spinal fixation system rod

LG - 00719192633148

Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK701G-WP
In Commercial Distribution

  • 00719192633148 ()
17HK701G-WP

  • Indirect flat panel x-ray detector

LG - 00719192633131

Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK700G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK700G-WP
In Commercial Distribution

  • 00719192633131 ()
17HK700G-WP

  • Indirect flat panel x-ray detector

LG - 00719192633124

Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
14HK701G-WP
In Commercial Distribution

  • 00719192633124 ()
14HK701G-WP

  • Indirect flat panel x-ray detector

LG - 00195174039687

Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HQ901G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
17HQ901G-BP
In Commercial Distribution

  • 00195174039687 ()
17HQ901G-BP

  • Indirect flat panel x-ray detector

LG - 00195174039663

Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HQ901G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
14HQ901G-BP
In Commercial Distribution

  • 00195174039663 ()
14HQ901G-BP

  • Indirect flat panel x-ray detector

LG - 00195174039496

Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 10HQ701G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
10HQ701G-BP
In Commercial Distribution

  • 00195174039496 ()
10HQ701G-BP

  • Indirect flat panel x-ray detector

LG - 00195174039472

Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HQ701G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
17HQ701G-BP
In Commercial Distribution

  • 00195174039472 ()
17HQ701G-BP

  • Indirect flat panel x-ray detector

LG - 00195174039458

Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HQ701G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
14HQ701G-BP
In Commercial Distribution

  • 00195174039458 ()
14HQ701G-BP

  • Indirect flat panel x-ray detector

Neuroline Cup - 05707480146703

Neurology surface electrodes
Ambu A/S
72620-M/27
In Commercial Distribution

  • 05707480146697 ()
  • 05707480146703 ()
  • 05707480146680 ()
  • 05707480153985 ()

  • Length: 200 Centimeter
72620-M/27

  • Analytical scalp electrode, single-use

Neuroline Cup - 05707480146581

Neurology surface electrodes
Ambu A/S
72615-M/27
In Commercial Distribution

  • 05707480146567 ()
  • 05707480146574 ()
  • 05707480146581 ()
  • 05707480153947 ()

  • Length: 150 Centimeter
72615-M/27

  • Analytical scalp electrode, single-use

Neuroline Cup - 05707480146451

Neurology surface electrodes
Ambu A/S
72610-M/27
In Commercial Distribution

  • 05707480146468 ()
  • 05707480146451 ()
  • 05707480146444 ()
  • 05707480153909 ()

  • Length: 100 Centimeter
72610-M/27

  • Analytical scalp electrode, single-use

SURGICAL INSTRUMENT - 07899995205483

DRIVE HANDPIECE
Sin Sistema de Implante Nacional S/A
CQCA 27
In Commercial Distribution

  • 07899995205483 ()
CQCA 27

  • Surgical screwdriver, single-use, non-sterile

Bausch + Lomb - 00757770485598

FOGLA AIR INJECTION CANNULA
Bausch & Lomb Incorporated
E4924 27
In Commercial Distribution

  • 00757770485598 ()
E4924 27

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Bausch + Lomb - 00757770433742

CANNULA AIR INJECTION 27GA
Bausch & Lomb Incorporated
E0499 27
In Commercial Distribution

  • 00757770433742 ()
E0499 27

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Bausch + Lomb - 00757770425075

HANDPIECE MCINTYRE
Bausch & Lomb Incorporated
E4395 27
In Commercial Distribution

  • 00757770425075 ()
E4395 27

  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

Tatum Surgical/Hand Tool - 00083208270048

Hand Tool #27 Adapter for Tatum ratchet to fit standard 4mm square drive
Suncoast Dental, Inc
Hand Tool / HT.27
In Commercial Distribution

  • 00083208270048 ()

  • Hand Tool #27 Adapter for Tatum ratchet to fit standard 4mm square drive
HT.27

  • Dental torque wrench adaptor

Rexious - 08809319789901

Transverse Link Set 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319789901 ()

  • Length: 90 Millimeter
OSM6206

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

Rexious - 08809319786276

Poly Screw B type (Double) 8.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319786276 ()

  • Length: 90 Millimeter
  • Diameter 8.5mm
FX.PD.8590

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

Rexious - 08809319786047

Rod C type (MIS) 5.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319786047 ()

  • Diameter 5.5mm
  • Length: 90 Millimeter
FX.RM.0090

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

Rexious - 08809319785873

Rod C type (MIS) 6.0 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319785873 ()

  • Length: 90 Millimeter
  • Diameter 6.0mm
FX.RM.1090

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

Rexious - 08809319785538

Rod B type (Curved) 5.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319785538 ()

  • Length: 90 Millimeter
  • Diameter 5.5mm
FE.RC.0090

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

Rexious - 08809319784401

Rod A type (Straight) 5.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319784401 ()

  • Diameter 5.5mm
  • Length: 90 Millimeter
FE.RS.0090

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

Rexious - 08809319783374

Poly Screw B type (Double) 8.0 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783374 ()

  • Diameter 8.0mm
  • Length: 90 Millimeter
FX.PD.8090

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

Rexious - 08809319783237

Poly Screw B type (Double) 7.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783237 ()

  • Length: 90 Millimeter
  • Diameter 7.5mm
FX.PD.7590

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

Rexious - 08809319782636

Poly Screw A type (Single) 8.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319782636 ()

  • Diameter 8.5mm
  • Length: 90 Millimeter
FX.PS.8590

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

Rexious - 08809319782490

Poly Screw A type (Single) 8.0 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319782490 ()

  • Length: 90 Millimeter
  • Diameter 8.0mm
FX.PS.8090

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

Rexious - 08809319782353

Poly Screw A type (Single) 7.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319782353 ()

  • Diameter 7.5mm
  • Length: 90 Millimeter
FX.PS.7590

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

Rexious - 08809319781752

Mono Screw B type (Double) 8.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319781752 ()

  • Length: 90 Millimeter
  • Diameter 8.5mm
FX.MD.8590

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

Rexious - 08809319781615

Mono Screw B type (Double) 8.0 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319781615 ()

  • Length: 90 Millimeter
  • Diameter 8.0mm
FX.MD.8090

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

Rexious - 08809319781479

Mono Screw B type (Double) 7.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319781479 ()

  • Length: 90 Millimeter
  • Diameter 7.5mm
FX.MD.7590

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

Rexious - 08809319780878

Mono Screw A type (Single) 8.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319780878 ()

  • Diameter 8.5mm
  • Length: 90 Millimeter
FX.MS.8590

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

Rexious - 08809319780731

Mono Screw A type (Single) 8.0 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319780731 ()

  • Length: 90 Millimeter
  • Diameter 8.0mm
FX.MS.8090

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

Rexious - 08809319780595

Mono Screw A type (Single) 7.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319780595 ()

  • Length: 90 Millimeter
  • Diameter 7.5mm
FX.MS.7590

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