FDA.reportPublic FDA data

Copioumed

Primary DI
04719882250804
Brand
Copioumed
Company
COPIOUMED INTERNATIONAL INC.
Model
SSN0B101-1
Device description
Copioumed’s scrub suits are protective outfits made for medical personnel for use in operating rooms when they might come in touch with an infectious substance or body fluid.
Published
2022-09-02
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
FXOSuit, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719882250801PackageGS15In Commercial Distribution
04719882250804PrimaryGS10
04719882250798Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471988225080114719882250801
04719882250804047198822508044719882250804
04719882250798047198822507984719882250798

GMDN Terms#

Term, Definition table
TermDefinition
Scrub suit, single-useA two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Contacts#

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

Regulatory Flags#

DUNS number
658318113
Device count
10
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
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
14719882251457CopioumedCTN3B104-12025-07-16
14719882251556CopioumedCTN3B201-12025-07-16
14719882251570CopioumedCTN3B202-12025-07-16
14719882251594CopioumedCTN3B203-12025-07-16
14719882251617CopioumedCTN3B204-12025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604599921Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2025-09-10
00889813060179Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060186Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060193Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060176Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060183Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060190Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
06921340881118customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340882115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340883112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340884119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340885116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340881115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340882112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340883119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340884116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340885113customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06973635612013MaoshengXianTao Maosheng Plastic Products Co., LtdFXO2023-03-31
10850044799593SURGYCOSurgyco LLCFXO2023-02-16
10850044799609SURGYCOSurgyco LLCFXO2023-02-16
10850044799616SURGYCOSurgyco LLCFXO2023-02-16
10850044799623SURGYCOSurgyco LLCFXO2023-02-16
10850044799630SURGYCOSurgyco LLCFXO2023-02-16
10850044799647SURGYCOSurgyco LLCFXO2023-02-16
10850044799654SURGYCOSurgyco LLCFXO2023-02-16
10850044799661SURGYCOSurgyco LLCFXO2023-02-16
10850044799678SURGYCOSurgyco LLCFXO2023-02-16
10850044799685SURGYCOSurgyco LLCFXO2023-02-16
00850044799596SURGYCOSurgyco LLCFXO2023-02-16
00850044799602SURGYCOSurgyco LLCFXO2023-02-16