AccessGUDID - DEVICE: Integra® Jarit® (10381780379829)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 185136
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 185-136
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780379829
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Finger Ring Cutter, 19.2mm Diameter, Replacement Blade for REF# 185-135

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?
13399	Ring cutter	A manually-operated instrument designed for cutting rings and other jewellery from fingers or other body appendages (e.g., the penis) when difficult to remove by other means. It is typically a scissors-like instrument that brings a serrated cutting wheel blade to bear on a thin support which is slipped beneath the ring or item to be removed; the operator rotates the cutting wheel manually by turning an attached handle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNS	RING CUTTER

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
Outer Diameter: 19.2 Millimeter

Device Record Status

Public Device Record Key: f4df3ce2-d82b-4710-bb9c-43a67621a192
Public Version Date: January 15, 2025
Public Version Number: 6
DI Record Publish Date: September 29, 2017