AccessGUDID - DEVICE: Gimmi (04049047779155)

GUDID

Device Identifier (DI) Information

Brand Name: Gimmi
Version or Model: UC.1511.13
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UC.1511.13
Company Name: Gimmi GmbH

Primary DI Number: 04049047779155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316152610 *Terms of Use

Device Description: VASECTOMY CLAMP POINTED, FOR SCALPEL-FREE VASECTOMY LENGTH 130 MM

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63552	Surgical A/V-shaped microvessel clamp	A hand-held surgical instrument designed to compress the severed end of a small vessel (e.g., blood vessel, vas deferens) to occlude the vessel, typically prior to anastomosis formation. Often referred to as an Acland clamp, it has an A-/V-shaped design whereby the vessel is slid into the mouth of the clamp up to the apex where it is compressed; it does not have a hinge/jaws (i.e., it is not forceps or a bulldog clamp). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDJ	Clamp, Surgical, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

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 Record Status

Public Device Record Key: 3fd5e0ef-3fd2-4d0c-9037-0003ea39335a
Public Version Date: April 19, 2024
Public Version Number: 1
DI Record Publish Date: April 11, 2024

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

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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