FDA.report

Gimmi

Primary DI
04049047679776
Brand
Gimmi
Company
Gimmi GmbH
Model
AA.1498.18
Catalog number
AA.1498.18
Device description
DEAN TONSIL SCISSORS SAW EDGE LENGTH 175 MM
Published
2025-04-16
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
KBMDissector, Tonsil

Product Code Classifications

CodeDeviceSpecialtyClass
KBMDissector, TonsilEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047679776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047679776040490476797764049047679776

GMDN Terms

TermDefinition
Tonsil scissorsA hand-held surgical instrument used to cut tonsil tissue during ear/nose/throat (ENT) surgery. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. The distal end of the blades may have different shapes and are typically round-nosed to prevent inadvertent trauma. Some types can have carbide inserts along the cutting edges. 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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