AccessGUDID - DEVICE: A Plus (00683534830154)

GUDID

Device Identifier (DI) Information

Brand Name: A Plus
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GS-8412-7S
Company Name: A PLUS INTERNATIONAL INC.

Primary DI Number: 00683534830154
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 191705904 *Terms of Use

Device Description: Bulk Gauze Sponges , 8"X8", 12 Ply, DualXRay Detectable, Steam Pretreated, Bleached White, Banded 10'S, 200 Pc(s)/Bag, 2000 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?
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFQ	Gauze/Sponge, Internal

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: 0d938b67-bf8b-4111-85f4-928410789b80
Public Version Date: October 27, 2022
Public Version Number: 1
DI Record Publish Date: October 19, 2022