FDA.report

VIVIT Supply

Primary DI
20810141930616
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
1121HW
Device description
Bouffant Cap, Spunbond, Large, Blue
Published
2023-09-15
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
FYFCap, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810141930616PackageGS15In Commercial Distribution
10810141930619PrimaryGS10
00810141930612Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193061620810141930616
1081014193061910810141930619
00810141930612008101419306128101419306120810141930612

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
119042597
Device count
250
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20810141933792VIVIT Supply201012026-02-26
20810141933808VIVIT Supply201022026-02-26
20810141933815VIVIT Supply201032026-02-26
20810141933822VIVIT Supply201042026-02-26
20810141933839VIVIT Supply201052026-02-26
20810141933877VIVIT Supply708812026-02-25
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20810141933747VIVIT Supply205512026-02-03
20810141933754VIVIT Supply205522026-02-03
20810141933761VIVIT Supply205532026-02-03
20810141933778VIVIT Supply205542026-02-03
20810141933785VIVIT Supply205552026-02-03
20810141933488VIVIT Supply1112LJ2025-09-18
20810141933495VIVIT Supply1113LJ2025-09-18
20810141933501VIVIT Supply1114LJ2025-09-18
20810141933518VIVIT Supply1115LJ2025-09-18
20810141933525VIVIT Supply1116LJ2025-09-18

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