AccessGUDID - DEVICE: SOFSORB OR TOWEL (00634916098914)

GUDID

Device Identifier (DI) Information

Brand Name: SOFSORB OR TOWEL
Version or Model: 49526153
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 49526153
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916098914
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: OR TOWEL SOFSORB 2TN NW 16.75X26 NW/"OR USE ONLY" ALPINE GREEN

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: d5a4781a-ddc9-431c-98aa-421a285cc0e3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 29, 2018