FDA.report

A Plus

Primary DI
80683534820434
Brand
A Plus
Company
A PLUS INTERNATIONAL INC.
Model
1
Catalog number
28300-NS
Device description
Bulk O.R. Towel, White, 17" x 23", Prewashed, Steam Pretreatment, 100 Pc(s)/Polybag, 4000 Pc(s)/Gaylord
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
FRLFiber, Medical, Absorbent

Product Code Classifications

CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
80683534820434PackageGS14000In Commercial Distribution
00683534820438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
8068353482043480683534820434
00683534820438006835348204386835348204380683534820438

GMDN Terms

TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. 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

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80683534870095SurgiCount+10621-008-1082023-08-04
80683534870101SurgiCount+10620-104-1802023-08-04
80683534870118SurgiCount+10620-104-3602023-08-04
80683534870125SurgiCount+10620-108-3602023-08-04
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80683534820595A Plus1FC-2435-S2022-11-18
70683534010234A Plus168-324G-N2022-11-17
80683534010248A Plus168-403W-G2022-11-17

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