FDA.reportPublic FDA data

A Plus

Primary DI
00683534010044
Brand
A Plus
Company
A PLUS INTERNATIONAL INC.
Model
1
Catalog number
68-331B-SPP
Device description
SURGEON CAP, UNIVERSAL,;800/CS
Published
2022-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80683534010040PackageGS1800In Commercial Distribution
00683534010044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8068353401004080683534010040
00683534010044006835340100446835340100440683534010044

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Regulatory Flags#

DUNS number
191705904
Device count
1
Premarket exempt
true
No natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604245002Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245057Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245101Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245200Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245309Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245354Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245408Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245453Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245507Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245552Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956007Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956052Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956106Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956205Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956304Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956359Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956403Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956458Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956502Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956557Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10195327657802Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYU2024-07-29
10097604245064Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245163Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245262Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245361Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245460Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245569Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245668Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245767Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245866Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28