AccessGUDID - DEVICE: Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 (00843356101812)

GUDID

Device Identifier (DI) Information

Brand Name: Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12
Version or Model: GIC190R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYGNUS MEDICAL L.L.C.

Primary DI Number: 00843356101812
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103169095 *Terms of Use

Device Description: Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R Version on Gator Clips - All clips are made w/ Barium Sulfate. Refer to GIC190.

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:	Yes
Prescription Use (Rx):	No
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?
64671	Sterilizer/disinfector rack instrument-holding insert, single-use	A device intended to be fitted into the rack/container/tray of a sterilizer or disinfector to hold, position, and sometimes protect a medical/surgical instrument(s) during a sterilization and/or disinfection procedure. It may be available in various forms including a spongy strip through which a portion of the instrument is inserted. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: a39d5941-4ad0-47f5-9ef0-bcd6f8acc47e
Public Version Date: January 08, 2025
Public Version Number: 1
DI Record Publish Date: December 31, 2024