FDA.reportPublic FDA data

Tisuthes

Primary DI
06970461300220
Brand
Tisuthes
Company
Shanghai Suokang Medical Implants Co.,Ltd.
Model
TPN01
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic SurgeryGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201153000Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd.2023-06-13OWR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970461300220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970461300220069704613002206970461300220

GMDN Terms#

Term, Definition table
TermDefinition
PTFE/carbon-fibre craniofacial tissue reconstructive materialA sterile device that is made up of polytetrafluoroethylene (PTFE), commonly known as Teflon, reinforced with carbon fibres to make a porous implant material. Such a device may be used in cosmetic surgery to restore the shape of the chin, jaw, nose, or bones and tissue near the eye. The device serves as a space-occupying substance and is shaped and formed by the surgeon. It can also be used for the coating of prosthetic devices. This is a single-use device.

Regulatory Flags#

DUNS number
723129701
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970461300015TisuthesTPS012026-07-22
06970461300022TisuthesTPS022026-07-22
06970461300039TisuthesTPS032026-07-22
06970461300046TisuthesTPS042026-07-22
06970461300053TisuthesTPS052026-07-22
06970461300060TisuthesTPS062026-07-22
06970461300077TisuthesTPS072026-07-22
06970461300084TisuthesTPS082026-07-22
06970461300091TisuthesTPS092026-07-22
06970461300107TisuthesTPS102026-07-22
06970461300114TisuthesTPS112026-07-22
06970461300121TisuthesTPS122026-07-22
06970461300138TisuthesTPR012026-07-22
06970461300145TisuthesTPR022026-07-22
06970461300152TisuthesTPR032026-07-22
06970461300169TisuthesTPR042026-07-22
06970461300176TisuthesTPR052026-07-22
06970461300183TisuthesTPR062026-07-22
06970461300190TisuthesTPR072026-07-22
06970461300206TisuthesTPR082026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970461300015TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300015TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300022TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300022TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300039TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300039TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300046TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300046TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300053TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300053TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300060TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300060TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300077TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300077TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300084TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300084TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300091TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300091TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300107TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300107TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300114TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300114TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300121TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300121TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300138TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300138TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300145TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300145TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22
06970461300152TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300152TisuthesShanghai Suokang Medical Implants Co.,Ltd.OWR2026-07-22