FDA.report

Gimmi

Primary DI
04049047643395
Brand
Gimmi
Company
Gimmi GmbH
Model
DA.1018.04
Catalog number
DA.1018.04
Device description
FERRIS-SMITH-KERRISON PUNCH, DETACHABLE 40° UPWARDS CUTTING, BITE 4 MM LENGTH 180 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
HTXRongeur

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047643395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047643395040490476433954049047643395

GMDN Terms

TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. 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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