FDA.reportPublic FDA data

N/A

Primary DI
04262494463051
Brand
N/A
Company
Doppkon GmbH & Co. KG
Model
A-100-520
Catalog number
A-100-520
Device description
Raptor Suture Passer Needle
Published
2025-12-04
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
HASNeedle, Neurosurgical Suture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HASNeedle, Neurosurgical SutureNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262494463051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262494463051042624944630514262494463051

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic suturing unitA manually-operated, surgical device intended to be used in combination with a compatible arthroscope to mechanically approximate the edges of an internal wound or incision, including muscle tears, with sutures during arthroscopy. A suture punch mechanism places the number of sutures desired by the surgeon at the site of the lesion. This is a reusable device intended to be sterilized prior to use.

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
04262494463112N/AA-001-338A-001-3382025-12-04
04262494463129N/AA-001-339A-001-3392025-12-04
04262494463143N/AA-100-735A-100-7352025-12-04
04262494463150N/AA-001-400A-001-4002025-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482103579Symmetry Rhoton®ASPEN SURGICAL PRODUCTS, INC.HAS2024-09-05
00887482103593Symmetry Rhoton®ASPEN SURGICAL PRODUCTS, INC.HAS2024-08-01
00190776354619MILLENNIUMAvalign Technologies, Inc.HAS2023-09-28
00190776355067MILLENNIUMAvalign Technologies, Inc.HAS2023-09-28
14026704796929PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
54026704796927PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
00887482096215Symmetry AdsonASPEN SURGICAL PRODUCTS, INC.HAS2022-08-24
00190776068585AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776068592AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776211912AvalignAvalign Technologies, Inc.HAS2021-11-03
00190660121549Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660121556Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660109707Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121563Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121570Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
10885403072819V. MuellerSTERIS CORPORATIONHAS2018-08-30