FDA.report

Gimmi

Primary DI
04049047697244
Brand
Gimmi
Company
Gimmi GmbH
Model
CY.2000.01
Catalog number
CY.2000.01
Device description
BAYONET-SHAPED MICRO CURETTE FIG.00, 45° UPWARDS, 2.5 X 3.5 MM LENGTH 205 MM, NOT FOR NEURO AND CARDIO
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
FZSCurette, Surgical, General Use

Product Code Classifications

CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047697244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047697244040490476972444049047697244

GMDN Terms

TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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

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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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