FDA.report

N/A

Primary DI
04262494464041
Brand
N/A
Company
Doppkon GmbH & Co. KG
Model
A-100-750
Catalog number
A-100-750
Device description
Nerve Root Retractor Edgefold Right WL 115mm, width 8mm
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HXBProbe

Product Code Classifications

CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04262494464041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04262494464041042624944640414262494464041

GMDN Terms

TermDefinition
Hand-held endoscopic retractor, reusableA hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
314157821
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04262494460029N/AA-001-450A-001-4502025-12-04
04262494460036N/AA-001-451A-001-4512025-12-04
04262494460043N/AA-001-452A-001-4522025-12-04
04262494460050N/AA-001-453A-001-4532025-12-04
04262494460067N/AA-001-454A-001-4542025-12-04
04262494460074N/AA-001-455A-001-4552025-12-04
04262494460081N/AA-001-456A-001-4562025-12-04
04262494460098N/AA-001-457A-001-4572025-12-04
04262494460104N/AA-001-458A-001-4582025-12-04
04262494460111N/AA-001-459A-001-4592025-12-04
04262494460128N/AA-001-460A-001-4602025-12-04
04262494460135N/AA-001-461A-001-4612025-12-04
04262494460142N/AA-001-462A-001-4622025-12-04
04262494460159N/AA-001-463A-001-4632025-12-04
04262494462962N/AA-001-337A-001-3372025-12-04
04262494462979N/AA-001-318A-001-3182025-12-04
04262494463051N/AA-100-520A-100-5202025-12-04
04262494463112N/AA-001-338A-001-3382025-12-04
04262494463129N/AA-001-339A-001-3392025-12-04
04262494463143N/AA-100-735A-100-7352025-12-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150069675Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-03-20
10705034577449N/AMedos International SàrlHXB2026-03-05
10889981443436SpecialsSeaspine Orthopedics CorporationHXB2026-03-03
10888857578197Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578203Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578630Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578647Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578654Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578661Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578678Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578685Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578692Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578708Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
03662663131551Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131568Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131575Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131582Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131599Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131605Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131612Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
00860014213458Introducer ProbeTETROUS, INC.HXB2026-02-10
00860014213472Pusher ProbeTETROUS, INC.HXB2026-02-10
00860014213496Introducer Probe - SJTETROUS, INC.HXB2026-02-10
00810158218833PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218840PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218857PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218864PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
10889981441531SpecialsSeaspine Orthopedics CorporationHXB2026-01-30
00840180544013General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29
00840180545188General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29