AccessGUDID - DEVICE: TOWEL PERVAL (00634916189629)

GUDID

Device Identifier (DI) Information

Brand Name: TOWEL PERVAL
Version or Model: 488K1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 488K1000
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916189629
Issuing Agency: GS1
Commercial Distribution End Date: September 07, 2021
Device Count: 144
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: TOWEL PERVAL GQT KAUM 18X32 WHT RM (98 8155) USE: 48810400

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):	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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14077	Surgical towel	A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 1e52ff5f-93d2-413d-895e-07bc9c532b9c
Public Version Date: July 03, 2023
Public Version Number: 3
DI Record Publish Date: January 29, 2018