FDA.reportPublic FDA data

Contodo Medical

Primary DI
10860013348790
Brand
Contodo Medical
Company
Contodo LLC
Model
DSGCTMS101
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212718000Surgical gownsXiantao Dingcheng Non-Woven Product Co., Ltd.2022-01-12FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013348793PrimaryGS10
10860013348790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013348793008600133487938600133487930860013348793
1086001334879010860013348790

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
127598607
Device count
40
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013348793Contodo Medical DSGCTMS1012025-07-02
00860013348779Contodo Medicsl SuppliesCTMS00032025-03-13
00860013348717Contodo Medicsl SuppliesCTMS00022025-03-13
00860013348786Contodo Medicsl SuppliesCTMS00072025-03-13
10860013348714Contodo Medicsl SuppliesCTMS00022025-03-13
10860013348738Contodo Medicsl SuppliesCTMS00032025-03-13
10860013348707Contodo Medicsl SuppliesCTMS00072025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918196756AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748412121AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748480953AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
00627755521002Lac-MacLac-Mac LimitedFYA2026-10-13
16931918113425AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143040AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143217AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143248AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918155159AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918182988AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918192208AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918195544AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918198286AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
04719882251900CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251924CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251948CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251962CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835214ViVi® PEEL-OFF TOGA PREMIUM M-LTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835238ViVi® PEEL-OFF TOGA PREMIUM 3XLTHI Total Healthcare Innovation GmbHFYA2026-07-22
10193489135909MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-07-17
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-06-25
50885380134560CARDINAL HEALTHCardinal Health 200, LLCFYA2026-06-24
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07