AccessGUDID - DEVICE: Gimmi (04049047095729)

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Device Identifier (DI) Information

Brand Name: Gimmi
Version or Model: T.0014.81
Catalog Number: T.0014.81
Company Name: Gimmi GmbH

Primary DI Number: 04049047095729
Issuing Agency: GS1
Device Count: 1

Device Description: BIPOLAR COAGULATION FORCEPS DETACHABLE, Ø 5 MM, LENGTH 34 CM KLEPPINGER SERRATED, COMPLETE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Endoscopic electrosurgical electrode, bipolar, reusable	An invasive, distal component of an electrosurgical system intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is a long thin device available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation; it does not include a handpiece with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Endoscopic electrosurgical electrode, bipolar, reusable

An invasive, distal component of an electrosurgical system intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is a long thin device available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation; it does not include a handpiece with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: May 05, 2017
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: Gimmi (04049047095729)