FDA.reportPublic FDA data

DUFNER Instrumente GmbH

Primary DI
04063763180330
Brand
DUFNER Instrumente GmbH
Company
DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
Model
12881-32
Device description
Valve 25 x 8 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
04063763180330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063763180330040637631803304063763180330

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
04063763180316DUFNER Instrumente GmbH12881-232024-03-11
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
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00810111228480RetractorTreace Medical Concepts, Inc.GAD2026-10-16
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00842102116513DynaTrac Retractor FramesFLEXBAR MACHINE CORPORATIONGAD2026-10-14
00190776434632MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434663MillenniumAvalign Technologies, Inc.GAD2026-10-12