A Plus

Basic Information

• Brand Name: A Plus
• Primary DI: 00683534830178
• Version / Model: 1
• Catalog Number: GS-8424-6S
• Company Name: A PLUS INTERNATIONAL INC.
• Labeler DUNS: 191705904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-19
• Public Version: 1
• Public Version Date: 2022-10-27
• Public Version Status: New
• Public Device Record Key: 4be35c29-9b59-4424-bd64-d93a62fe9790

Device Description

Bulk Gauze Sponges , 8"X8", 24 Ply,XRay Detectable, Steam Pretreated, Bleached White, Banded 10'S, 100 Pc(s)/Bag, 1000 Pc(s)/Case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Radiation Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFQ	Gauze/Sponge, Internal	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	80683534830174	GS1	Case	1000	In Commercial Distribution
Primary	00683534830178	GS1