FDA.reportPublic FDA data

ALPHADUR FORTIS

Primary DI
04049047526568
Brand
ALPHADUR FORTIS
Company
Gimmi GmbH
Model
S.0598.55
Device description
ALPHADUR FORTIS SCISSORS;BLUNT, STRAIGHT;WORKING LENGTH 160 MM
Published
2023-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047526568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047526568040490475265684049047526568

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic scissors, reusableA hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags#

DUNS number
316152610
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049047003137GimmiAA.1502.192026-05-18
04049047787815GimmiLIG.4148.30LIG.4148.302025-03-20
04049047788119GimmiLIG.4148.98LIG.4148.982025-03-20
04049047657545NAE.8230.48 LED2023-05-03
04049047657569GimmiE.8300.48 LEDE.8300.48 LED2023-02-14
04049047042563GimmiE.8230.45XE.8230.45X2017-05-05
04049047043164GimmiE.8300.35E.8300.352017-05-05
04049047043171GimmiE.8300.48E.8300.482017-05-05
04049047043430GimmiE.8997.00E.8997.002017-05-05
04049047043447GimmiE.8998.01E.8998.012017-05-05
04049047126379GimmiE.8230.41E.8230.412017-05-05
04049047127086GimmiE.8000.00E.8000.002017-05-05
04049047127246GimmiE.8230.45X SETE.8230.45X SET2017-05-05
04049047203322GimmiE.8300.45XE.8300.45X2017-05-05
04049047631675GimmiE.8998.02E.8998.022017-05-05
04049047643289GimmiE.8300.48X SETE.8300.48X SET2017-05-05
04049047064725GimmiM.1701.08M.1701.082025-05-20
04049047064848GimmiM.1721.12M.1721.122017-05-05
04049047788553GimmiCAM.1113.002026-03-04
04049047788577GimmiCAM.1113.902026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039702SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039719SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039726SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039733SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039740SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039757SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039764SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039771SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
G425050183SCD0My MedicalMy Medical Store LLCLRW2026-05-04
G425050933SC0My MedicalMy Medical Store LLCLRW2026-03-27
09348811003119INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-03-18
09348811000798INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000804INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000842INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000859INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000866INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811153494INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811173058INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
10198956213302CARDINAL HEALTHCardinal Health 200, LLCLRW2025-11-24
09348811000811INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001313INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001702INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811002433INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003171INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003805INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811007117INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
G453CA306140PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-28
G453CA303160PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA331700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA350670PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21