AccessGUDID - DEVICE: A Plus (00683534820506)

GUDID

Device Identifier (DI) Information

Brand Name: A Plus
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 31319604
Company Name: A PLUS INTERNATIONAL INC.

Primary DI Number: 00683534820506
Issuing Agency: GS1
Commercial Distribution End Date: November 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 191705904 *Terms of Use

Device Description: ORTTG-6004 STERL GREEN;O.R. TOWEL PW 4/PH, 80 Pc(s)/Case

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):	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?
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 [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
Radiation 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: 93d463e5-6343-418e-89d7-5b150c775112
Public Version Date: November 17, 2022
Public Version Number: 2
DI Record Publish Date: October 19, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
70683534820505	4	00683534820506	2022-11-16	Not in Commercial Distribution	Inner Pack
80683534820502	20	70683534820505	2022-11-16	Not in Commercial Distribution	Case