FDA.report

A Plus

Primary DI
80683534830280
Brand
A Plus
Company
A PLUS INTERNATIONAL INC.
Model
1
Catalog number
GZ-4416-B
Device description
4"X4", 16Ply, Bleached White, 10 Pc(s)/Bundle, 200 Pc(s)/Bag, 2000 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
false
Single use
true

Related Records

Product Codes

CodeName
EFQGauze/Sponge, Internal

Product Code Classifications

CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
80683534830280PackageGS12000In Commercial Distribution
00683534830284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
8068353483028080683534830280
00683534830284006835348302846835348302840683534830284

GMDN Terms

TermDefinition
General-purpose surgical spongeA non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, 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 or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.

Sterilization Methods

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 DIBrandModelCatalogPublished
00683534090343RegardA3PMSKUL4-REG2025-08-06
80683534080616A Plus1SC44078-1F2022-12-21
80683534040016A Plus144-0040-8718-32024-01-18
80683534040023A Plus144-0040-8719-12024-01-18
80683534040030A Plus170-2004-4277-32024-01-18
00683534090282A Plus168-8607-G2023-08-04
00683534090305A Plus168-8608-G2023-08-04
00683534090329A Plus168-8609-B2023-08-04
80683534870095SurgiCount+10621-008-1082023-08-04
80683534870101SurgiCount+10620-104-1802023-08-04
80683534870118SurgiCount+10620-104-3602023-08-04
80683534870125SurgiCount+10620-108-3602023-08-04
70683534060536A Plus168-901B2022-12-21
00683534090206SURGIPLUS168-8508-G2023-01-03
00683534090220SURGIPLUS168-8538-B2023-01-03
80683534820571A Plus1FC-2419-S2022-11-18
80683534820588A Plus1FC-2435-P2022-11-18
80683534820595A Plus1FC-2435-S2022-11-18
70683534010234A Plus168-324G-N2022-11-17
80683534010248A Plus168-403W-G2022-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10192253067880ASOCardinal Health 200, LLCEFQ2026-01-20
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30192253045905CurityCardinal Health 200, LLCEFQ2024-11-12
50192253045916CurityCardinal Health 200, LLCEFQ2024-09-10
10630094194117Bioseal Inc.BIOSEALEFQ2023-10-11
50192253047521CurityCardinal Health 200, LLCEFQ2023-10-09
50192253047569CurityCardinal Health 200, LLCEFQ2023-10-09
50732224004254Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004261Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004278Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004285Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004292Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004308Preminum All-Gauze SpongesCROSSTEX INTERNATIONAL, INC.EFQ2023-07-17
50732224004247All-Gauze Sponges PremiumCROSSTEX INTERNATIONAL, INC.EFQ2023-06-22
00766588110110637 - Certi-Gauze Pads - 3"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110141638 - Certi-Gauze Compress - 18"x 36" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110172639 - Certi-Gauze Compress - 36"x 36" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110219640 - Certi-Gauze Compress - 24"x 72" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110301628 - Certi-Non-Stick Pads - 2"x 3" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588310039Certi-Non Stick Pads - 2"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312057Certi-Gauze Pads - 3"x 3" - 100/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312095Certi-Gauze Pads - 2"x 2" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312101Certi-Gauze Pads - 3"x 3" - 10/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312118Certi-Gauze Pads - 3"x 3" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588312132Certi-Gauze Pads - 4"x 4" - 25/BoxCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110028622 - Certi-Gauze Bandage Compress - 2" - 4/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110059623 - Certi-Gauze Bandage Compress - 3" - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110080624 - Certi-Gauze Bandage Compress - 4" - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110240634 - Certi-Gauze Roll - 2" x 6 yards - 2/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27
00766588110271635 - Certi-Gauze Roll - 4" x 6 yards - 1/UnitCertified Safety Manufacturing, Inc.EFQ2023-01-27