AccessGUDID - DEVICE: KMEDIC (24026704261196)

GUDID

Device Identifier (DI) Information

Brand Name: KMEDIC
Version or Model: IPN013000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KM29434
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 24026704261196
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: BLADE ONLY FOR RING CUTTER

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
Length: 2 Centimeter

Device Record Status

Public Device Record Key: 7f16d388-4cfb-4193-8659-712f5cfd9192
Public Version Date: July 07, 2023
Public Version Number: 3
DI Record Publish Date: September 15, 2018