AccessGUDID - DEVICE: Gimmi (04049047123361)

GUDID

Device Identifier (DI) Information

Brand Name: Gimmi
Version or Model: N.8299.04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N.8299.04
Company Name: Gimmi GmbH

Primary DI Number: 04049047123361
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316152610 *Terms of Use

Device Description: O-RING FOR ROTATABLE ARTHROSHEATH 7.65 X 1.78 MM MADE OF RED SILICONE

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

GMDN Preferred Term Name	GMDN Definition
Audio cassette tape	A device that contains a magnetic tape (band) upon which audio information is recorded and stored for playback or documentation. The tape spools on integrated reels which are activated by the recording/playing device utilized. This is a reusable device for general-purpose use.

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 742a62e5-9f35-4e02-814b-15bf86e7ac9f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 05, 2017