FDA.reportPublic FDA data

Copioumed

Primary DI
04719882253485
Brand
Copioumed
Company
Copious International Inc.
Model
SCN0W171-1
Device description
Copioumed Bouffant Cap provides an ideal headwear for a higher level of protection and comfort. The single-use cap features a latex-free elastic band around its circumference. This helps prevent allergic reactions that are due to exposure to latex . Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre.
Published
2023-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719882253482PackageGS14In Commercial Distribution
04719882253485PrimaryGS10
04719882253478Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225348214719882253482
04719882253485047198822534854719882253485
04719882253478047198822534784719882253478

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.

Contacts#

Phone, Email table
PhoneEmail
+886227721815info@gcv.com.tw

Regulatory Flags#

DUNS number
527237481
Device count
150
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719882252761Copioumed MS031W2023-08-25
04719882252785CopioumedMS031B2023-08-25
04719882252808Copioumed MS031G2023-08-25
04719882252822CopioumedMS031P2023-08-25
04719882252846CopioumedMS031BL2023-08-25
04719882252860CopioumedMS032W2023-08-25
04719882252884CopioumedMS032B2023-08-25
04719882252907CopioumedMS032G2023-08-25
04719882252921CopioumedMS032P2023-08-25
04719882252945CopioumedMS032BL2023-08-25
04719882252969CopioumedMS041W2023-08-25
04719882252983CopioumedMS041B2023-08-25
04719882253003CopioumedMS041G2023-08-25
04719882253027CopioumedMS041P2023-08-25
04719882253041CopioumedMS041BL2023-08-25
04719882253065CopioumedMS042W2023-08-25
04719882253089CopioumedMS042B2023-08-25
04719882253102CopioumedMS042G2023-08-25
04719882253126CopioumedMS042P2023-08-25
04719882253140CopioumedMS042BL2023-08-25

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TQ26126152001Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
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