FDA.report

Gimmi

Primary DI
04049047031697
Brand
Gimmi
Company
Gimmi GmbH
Model
CA.1154.24
Catalog number
CA.1154.24
Device description
LEBSCHE STERNUM CHISEL LENGTH 245 MM
Published
2025-05-06
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
HTZInstrument, Cutting, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047031697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047031697040490470316974049047031697

GMDN Terms

TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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

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00810212930497SURGIPROSSurgipros, LLCHTZ2026-05-22
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00190376538952Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
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00840180544662General InstrumentsALPHATEC SPINE, INC.HTZ2025-12-31
10603295553663ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553670ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553687ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553694ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553700ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295554929ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
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00196449033485Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033492Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033584Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033607Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033621Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02