FDA.reportPublic FDA data

Copioumed

Primary DI
04719882252549
Brand
Copioumed
Company
COPIOUMED INTERNATIONAL INC.
Model
SCN0B501-1
Device description
COPIOUMED Headwear is designed to prevent hair and scalp particles from shedding to protect the patient from the risk of infection. Headwear is also worn by medical personnel in other environments for hygiene reasons. Our wide range of headwear offers different styles, covering requirements for many types of operations and different shapes and sizes of heads and hairstyles. Single-use and non-sterile.
Published
2024-11-06
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
14719882252546PackageGS18In Commercial Distribution
04719882252549PrimaryGS10
04719882252532Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225254614719882252546
04719882252549047198822525494719882252549
04719882252532047198822525324719882252532

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
120
Premarket exempt
true
Lot or batch
true
Expiration date on label
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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Primary DI, Brand, Company table
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10840330706671ProCureTwin Med, LLCFYF2026-05-05
20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
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