FDA.reportPublic FDA data

Copioumed

Primary DI
04719882250477
Brand
Copioumed
Company
COPIOUMED INTERNATIONAL INC.
Model
SCN0B201-1
Device description
Copioumed Surgical Cap with Ties offers a comfortable and enhanced fit for wearers, as it is equipped with ties on the back for an adjustable size. The wide-forehead surgical cap’s design also ensures a close fit, especially for people with long hair. In addition, the wide and flat forehead contains no elastic, so this surgical cap won’t leave a mark. Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre.
Published
2022-08-31
Public version status
Update
Distribution status
Not 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
14719882250474PackageGS15Not in Commercial Distribution
04719882250477PrimaryGS10
04719882250460Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225047414719882250474
04719882250477047198822504774719882250477
04719882250460047198822504604719882250460

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
658318113
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719882251900CopioumedSGS3B102-12026-07-31
04719882251924CopioumedSGS3B103-12026-07-31
04719882251948CopioumedSGS3B104-12026-07-31
04719882251962CopioumedSGS3B201-12026-07-31
04719882251887CopioumedSGS3B101-12026-06-25
04719882251399CopioumedCTN3B101-12025-07-16
04719882251412CopioumedCTN3B102-12025-07-16
04719882251436CopioumedCTN3B103-12025-07-16
04719882251450CopioumedCTN3B104-12025-07-16
04719882251559CopioumedCTN3B201-12025-07-16
04719882251573CopioumedCTN3B202-12025-07-16
04719882251597CopioumedCTN3B203-12025-07-16
04719882251610CopioumedCTN3B204-12025-07-16
04719882251719CopioumedCTN3B301-12025-07-16
04719882251733CopioumedCTN3B302-12025-07-16
04719882251757CopioumedCTN3B303-12025-07-16
04719882251771CopioumedCTN3B304-12025-07-16
14719882251396CopioumedCTN3B101-12025-07-16
14719882251419CopioumedCTN3B102-12025-07-16
14719882251433CopioumedCTN3B103-12025-07-16

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