FDA.reportPublic FDA data

DUFNER Instrumente GmbH

Primary DI
04063763180316
Brand
DUFNER Instrumente GmbH
Company
DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
Model
12881-23
Device description
Frame only 75 x 57 mm for Dufner thoracic and abdominal retractor
Published
2024-03-11
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04063763180316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063763180316040637631803164063763180316

GMDN Terms#

Term, Definition table
TermDefinition
Rib spreader, reusableA self-locking surgical instrument designed to force apart two adjacent ribs to permit examination or intervention in the thoracic cavity. This device will typically have two interchangeable blades at the distal end that hook over the ribs to be parted, and a ratchet mechanism along its horizontal bar to adjust the blades and maintain its set position once it has been set. It is also known as a rib retractor and is available in various designs and sizes. It is typically made of high-grade stainless steel but types used for paediatrics may be made of corrosive resistant aluminium (Al). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
327980801
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
04063763186493DUFNER Instrumente GmbH26943-022024-03-11
04063763186554DUFNER Instrumente GmbH26943-062024-03-11
04063763200533DUFNER Instrumente GmbH20941-302024-03-11
04063763200601DUFNER Instrumente GmbH20943-042024-03-11
04063763200793DUFNER Instrumente GmbH20941-012024-03-11
04063763201790DUFNER Instrumente GmbH20943-542024-03-11
04063763202018DUFNER Instrumente GmbH20943-602024-03-11
04063763202070DUFNER Instrumente GmbH20943-612024-03-11
04063763156168DUFNER Instrumente GmbH15-11181-202024-03-11
04063763157820DUFNER Instrumente GmbH12-06110-062024-03-11
04063763158247DUFNER Instrumente GmbH04-11020-032024-03-11
04063763160318DUFNER Instrumente GmbH04-11020-102024-03-11
04063763177446DUFNER Instrumente GmbH27913-112024-03-11
04063763178986DUFNER Instrumente GmbH27996-012024-03-11
04063763180330DUFNER Instrumente GmbH12881-322024-03-11
04063763186462DUFNER Instrumente GmbH26943-002024-03-11
04063763186707DUFNER Instrumente GmbH26944-022024-03-11
04063763186714DUFNER Instrumente GmbH26944-032024-03-11
04063763189661DUFNER Instrumente GmbH26943-212024-03-11
04063763199684DUFNER Instrumente GmbH20907-172024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397463MillenniumAvalign Technologies, Inc.GAD2026-07-16
07613327651133VersiQuadSTRYKER CORPORATIONGAD2026-07-16
00190776395483MillenniumAvalign Technologies, Inc.GAD2026-07-14
B382SD123750Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123760Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123780Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD124326191140Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
G453152901750PEAK MEDICALPeak Medical Distribution Inc.GAD2026-07-14
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10