FDA.reportPublic FDA data

ePTFE Sheet

Primary DI
M724EPTFESHEET0631
Brand
ePTFE Sheet
Company
IMPLANTECH ASSOCIATES, INC.
Model
Size: 9cm x 6cm x 6mm
Catalog number
EPTFE-SHEET-063
Device description
ePTFE Sheet
Published
2020-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071470000IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXImplantech Associates, Inc.2007-08-31FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M724EPTFESHEET0631PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
784664955
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M724MCTBL10GF11Silicone Block, Grey, Firm 50 (EZ)Size: 14.5cm x 7.7cm x 1.0 cmMCT-BL-1.0-GF12026-04-16
M724MCTBL10GF21Silicone Block, Grey, Firm 50 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-GF22026-04-16
M724MCTBL10OF1Silicone Block, Opaque, Firm 40 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-OF2026-04-16
M724MCTBL13GM1Silicone Block, Grey, Medium 35 (EZ)Size: 15.0cm x 7.6cm x 1.3cmMCT-BL-1.3-GM2026-04-16
M724SMCOBL20FF1Silicone BlockSMCO-BL-2.0-FFSMCO-BL-2.0-FF2026-01-28
M724SMCOBL20OF1Silicone BlockSMCO-BL-2.0-OFSMCO-BL-2.0-OF2026-01-28
M724SMCOBL20OVS1Silicone BlockSMCO-BL-2.0-OVSSMCO-BL-2.0-OVS2026-01-28
M724SMCOBL20WF1Silicone BlockSMCO-BL-2.0-WFSMCO-BL-2.0-WF2026-01-28
M724SMCOBL20WVS1Silicone BlockSMCO-BL-2.0-WVSSMCO-BL-2.0-WVS2026-01-28
M724SLV6341Gelzone® Shoulder SleeveSLV634SLV6342023-06-22
M724NGBL20WMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-WM-EZ-NS2025-08-27
M724NGBL20CVFNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-CVF-NS2025-08-27
M724NGBL20FFEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FF-EZ-NS2025-08-27
M724NGBL20FMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FM-EZ-NS2025-08-27
M724NGBL20FSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FS-NS2025-08-27
M724NGBL20OVSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-OVS-NS2025-08-27
M724NGBL20RFM30EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFM30-EZ-NS2025-08-27
M724NGBL20RFS15EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS15-EZ-NS2025-08-27
M724NGBL20RFS20EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS20-EZ-NS2025-08-27
M724NGBL20RFSEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS-EZ-NS2025-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970461300015TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300022TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300039TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300046TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300053TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300060TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300077TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300084TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300091TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300107TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300114TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300121TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300138TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300145TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300152TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300169TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300176TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300183TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300190TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300206TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300213TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300220TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300237TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300244TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300251TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300268TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300275TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300282TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300299TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300305TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22