FDA.reportPublic FDA data

N/A

Primary DI
04262494461231
Brand
N/A
Company
Doppkon GmbH & Co. KG
Model
A-100-126
Catalog number
A-100-126
Device description
Endoscopic Kerrison Handle 140mm x 125mm
Published
2025-09-11
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

Product Codes#

Code, Name table
CodeName
LRYPunch, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262494461231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262494461231042624944612314262494461231

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
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 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
08681506800282SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2026-02-17
08681506800299SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2026-02-17
08681506800268SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-25
08681506800275SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-25
08681506800060SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800077SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800091SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800107SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800114SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800121SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800138SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800145SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800152SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800169SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800176SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800183SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800190SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800206SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800213SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800220SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800237SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800244SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800251SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800015SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800022SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800039SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800046SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800053SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800084SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
04262494460029N/ADoppkon GmbH & Co. KGLRY2025-12-04