AccessGUDID - DEVICE: Medline (00080196288406)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: MDT2168104XR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MDT2168104XR
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 00080196288406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: TOWEL,OR,DSP,ST,GREEN,DLX,XR,4/PK,20PK/C

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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
Surgical towel	A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, surgical
FRL	FIBER, MEDICAL, ABSORBENT

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: 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: 02aa6835-73c6-40fd-8ec8-8e0dfc24fbee
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 14, 2016