FDA.reportPublic FDA data

Gimmi

Primary DI
04049047114086
Brand
Gimmi
Company
Gimmi GmbH
Model
Z.3235.31
Catalog number
Z.3235.31
Device description
ALPHATRIPART BIOPSY FORCEPS SPOON Ø 5 MM, NEEDLE LENGTH 360 MM, MONOPOLAR
Published
2017-05-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047114086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047114086040490471140864049047114086

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags#

DUNS number
316152610
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049047110682GimmiZ.0005.23Z.0005.232017-05-05
04049047111146GimmiZ.0530.60Z.0530.602017-05-05
04049047111474GimmiZ.0560.01Z.0560.012017-05-05
04049047111528GimmiZ.0560.60Z.0560.602017-05-05
04049047111535GimmiZ.0561.01Z.0561.012017-05-05
04049047111559GimmiZ.0561.60Z.0561.602017-05-05
04049047111580GimmiZ.1025.24Z.1025.242017-05-05
04049047111597GimmiZ.1025.60Z.1025.602017-05-05
04049047111801GimmiZ.1139.02Z.1139.022017-05-05
04049047111818GimmiZ.1139.60Z.1139.602017-05-05
04049047111832GimmiZ.1140.02Z.1140.022017-05-05
04049047111849GimmiZ.1140.60Z.1140.602017-05-05
04049047111863GimmiZ.1235.02Z.1235.022017-05-05
04049047111870GimmiZ.1235.60Z.1235.602017-05-05
04049047113973GimmiZ.3035.60Z.3035.602017-05-05
04049047114055GimmiZ.3235.01Z.3235.012017-05-05
04049047114109GimmiZ.3235.60Z.3235.602017-05-05
04049047114604GimmiZ.4536.02Z.4536.022017-05-05
04049047114611GimmiZ.4536.60Z.4536.602017-05-05
04049047114765GimmiZ.5239.60Z.5239.602017-05-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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