FDA.reportPublic FDA data

SURGICAL DRAPE

Primary DI
08809783490419
Brand
SURGICAL DRAPE
Company
UNICO GLOBAL INC
Model
SA-2001DR
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
08809783490419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809783490419088097834904198809783490419

GMDN Terms#

Term, Definition table
TermDefinition
Surgical dressing/drape kit, single-useA collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690513726
Device count
1
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
08809783490402SURGICAL CAPSSA-2001CA2022-03-18
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

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Primary DI, Brand, Company table
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00810219420014American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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