FDA.reportPublic FDA data

N/A

Primary DI
04262494462559
Brand
N/A
Company
Doppkon GmbH & Co. KG
Model
A-001-203
Catalog number
A-001-203
Device description
Tendon Stripper Open OD 9.0mm, WL 330mm
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRTStripper, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262494462559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262494462559042624944625594262494462559

GMDN Terms#

Term, Definition table
TermDefinition
Tendon stripperA hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314157821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445944728SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944735SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944742SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944759SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944766SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944773SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944780SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944797SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944827SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944834SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304495SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304501SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304518SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346211SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346235SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346242SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
00190776419929MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776419936MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776416454MillenniumAvalign Technologies, Inc.HRT2026-02-16
00190776416249MillenniumAvalign Technologies, Inc.HRT2026-02-12
00190776416195MillenniumAvalign Technologies, Inc.HRT2026-02-06
04262494463112N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494463129N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494462542N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462566N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462573N/ADoppkon GmbH & Co. KGHRT2025-12-01
B7685410380Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
B7685410410Buxton BioMedicalBuxton Biomedical IncHRT2025-09-24
00816342024488STRIPPER, SURGICALPARCUS MEDICAL LLCHRT2025-09-16
00757770409112Bausch + LombBausch & Lomb IncorporatedHRT2025-08-15