FDA.reportPublic FDA data

A Plus

Primary DI
70683534840442
Brand
A Plus
Company
A PLUS INTERNATIONAL INC.
Model
1
Catalog number
21-1836-1
Device description
18"X36", Prewashed, Bleached White, 3 Pc(s)/Pack, 60 Pc(s)/Case
Published
2022-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70683534840442PackageGS13In Commercial Distribution
80683534840449PackageGS120In Commercial Distribution
00683534840443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
7068353484044270683534840442
8068353484044980683534840449
00683534840443006835348404436835348404430683534840443

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical spongeA 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Moist Heat or Steam Sterilization;Radiation Sterilization

Regulatory Flags#

DUNS number
191705904
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00683534820513A Plus19206-JB2022-10-19
00683534820544A Plus1OR-1740-JB2022-10-19
00683534040010A Plus144-0040-8718-32024-01-18
00683534040027A Plus144-0040-8719-12024-01-18
00683534040034A Plus170-2004-4277-32024-01-18
00683534090336RegardA3PMSKUL4-REG2025-08-06
00683534090343RegardA3PMSKUL4-REG2025-08-06
00683534850015A Plus1SEP1525-12022-10-19
00683534850022A Plus1SNA0304-12022-10-19
00683534850039A Plus1SAB0810-12022-10-19
00683534850046A Plus1SAB0875-12022-10-19
00683534850053A Plus1AB0509-N2022-10-19
00683534850060A Plus1AB0810-N2022-10-19
00683534850077A Plus1AB0875-N2022-10-19
00683534850084A Plus1NG-2204-32022-10-19
00683534850091A Plus1NG-3304-32022-10-19
00683534850107A Plus1NG-4404-32022-10-19
00683534850114A Plus1SDR4406-22022-10-19
00683534850121A Plus1SIV2206-22022-10-19
00683534850138A Plus1NG-2203-32022-10-19

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