FDA.report

Gimmi

Primary DI
04049047699590
Brand
Gimmi
Company
Gimmi GmbH
Model
DA.1133.42
Catalog number
DA.1133.42
Device description
BLAKESLEY NASAL CUTTING FORCEPS STRAIGHT, 4.2 MM, THROUGH-CUTTING LENGTH 110 MM
Published
2025-05-07
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

Related Records

Contact Domains

Product Codes

CodeName
KAEForceps, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047699590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047699590040490476995904049047699590

GMDN Terms

TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags

DUNS number
316152610
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
04049047788553GimmiCAM.1113.002026-03-04
04049047788577GimmiCAM.1113.902026-03-04
04049047788584GimmiCAM.1111.022026-03-04
04049047788607GimmiLIG.1110.002026-03-04
04049047783121GimmiS.2519.412025-12-03
04049047075295GimmiQO.1003.03QO.1003.032025-05-21
04049047075301GimmiQO.1003.04QO.1003.042025-05-21
04049047075318GimmiQO.1003.05QO.1003.052025-05-21
04049047075325GimmiQO.1003.06QO.1003.062025-05-21
04049047075332GimmiQO.1003.08QO.1003.082025-05-21
04049047075417GimmiQO.1005.04QO.1005.042025-05-21
04049047075424GimmiQO.1005.05QO.1005.052025-05-21
04049047075431GimmiQO.1005.06QO.1005.062025-05-21
04049047076452GimmiQO.1170.03QO.1170.032025-05-21
04049047076469GimmiQO.1170.04QO.1170.042025-05-21
04049047076612GimmiQO.1173.03QO.1173.032025-05-21
04049047077077GimmiQO.1430.08QO.1430.082025-05-21
04049047077084GimmiQO.1430.14QO.1430.142025-05-21
04049047078005GimmiQO.2050.04QO.2050.042025-05-21
04049047078043GimmiQO.2052.02QO.2052.022025-05-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09348811103338INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-16
09348811103321INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-09
24026704934472PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934489PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934502PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934519PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934526PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934533PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934540PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934557PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934571PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934588PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934625PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934632PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
00810123209842Adler Instrument CompanyAdler, Inc.KAE2026-03-03
00190776417413MillenniumAvalign Technologies, Inc.KAE2026-02-27
00190776417468MillenniumAvalign Technologies, Inc.KAE2026-02-27
00848657078214AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
00848657078221AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
09008737448905SoftGrip Forceps 2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
09008737448912SoftGrip Forceps SR2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
G04362076B0BEARBear-Ent, LLCKAE2026-02-03
09348811103659INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
09348811103673INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
04046826104276Medicon ForcepsMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2025-12-15
09348811105424INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811129017INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811104199INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104229INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104328INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01