FDA.reportPublic FDA data

SURGICAL CAPS

Primary DI
08809783490402
Brand
SURGICAL CAPS
Company
UNICO GLOBAL INC
Model
SA-2001CA
Published
2022-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08809783490402PrimaryGS10
08809783490457Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809783490402088097834904028809783490402
08809783490457088097834904578809783490457

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
690513726
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809783490426SURGICAL MASKSA-2001SM2022-03-18
08809783490587Unico High Performance Surgical MaskSM-301E2022-03-18
08809783490594Unico High Performance Surgical MaskSM-301T2022-03-18
08809783490600Unico High Performance Surgical Mask With Face ShieldSM-301FS2022-03-18
08809783490617Unico High Performance Surgical Mask With Face ShieldSM-301FST2022-03-18
08809783490303DISPOSABLE NITRILE GLOVESA-2001NG2022-03-18
08809783490310FACE SHIELD MASKSA-2001FSM2022-03-18
08809783490327MEDICAL APRONSA-2001MA2022-03-18
08809783490433SURGICAL MASK WITH FACE SHIELDSA-2001MFS2022-03-18
088097834906243PLY SURGICAL MASKFM-EU20012022-03-18
088097834906314PLY SURGICAL MASKFM-EU20022022-03-18
08809783490105Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-S2022-03-18
08809783490112Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-M2022-03-18
08809783490129Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-L2022-03-18
08809783490136Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XL2022-03-18
08809783490143Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XXL2022-03-18
08809783490150Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-S2022-03-18
08809783490167Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-M2022-03-18
08809783490174Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-L2022-03-18
08809783490181Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-XL2022-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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10097604956205Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956304Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
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10097604956458Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
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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