AccessGUDID - DEVICE: Coleman Luer Lock Cap (00081317023487)

GUDID

Device Identifier (DI) Information

Brand Name: Coleman Luer Lock Cap
Version or Model: COL-LLCAP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: COL-LLCAP
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317023487
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: Coleman Luer Lock Cap

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):	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
Syringe tip cap	A device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
MUU	System, suction, lipoplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981172	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 99ce393b-b73f-4ad7-afab-f005d962117c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 14, 2016