FDA.reportPublic FDA data

SFAM

Primary DI
00854804007013
Brand
SFAM
Company
SURGICAL TECHNOLOGY LABORATORIES INC
Model
SFAM803
Catalog number
SFAM803
Device description
SFAM803 ePTFE Block 1.5cm X 7cm
Published
2017-01-05
Public version status
Update
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
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021889000SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)Surgical Technology Laboratories, Inc.2002-10-16KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854804007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854804007013008548040070138548040070130854804007013

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
080380106
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854804007006SFAMSFAM603SFAM6032017-01-05
00854804007037SFAMSFAM503SFAM5032017-01-05
00854804007259SFAM PledgetPLG-6-RD2025-07-15
00854804007129SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 1.6mm2024-09-30
00854804007136SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 2.0mm2024-09-30
00854804007143SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 1.6mm2024-09-30
00854804007150SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 2.0mm2024-09-30
00854804007167SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 1.6mm2024-09-30
00854804007174SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 2.0mm2024-09-30
00854804007198SurgiPlast Nasal SplintSurgiPlast - Small - White Color - 1.6mm2024-09-30
00854804007204SurgiPlast Nasal SplintSurgiPlast - Small - White - 2.0mm2024-09-30
00854804007211SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 1.6mm2024-09-30
00854804007228SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 2.0mm2024-09-30
00854804007235SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 1.6mm2024-09-30
00854804007242SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 2.0mm2024-09-30
00851988007983Saf-T-Vac Smoke and Fluid EvacuatorST9000SST9000S2017-07-06
00854804007068PureForm6PN01*6PN01*2021-08-30
00854804007075PureForm4PN01*4PN01*2021-08-30
00854804007082PureForm5PN01*5PN01*2021-08-30
00850987007079PureForm2NDP012NDP012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324542HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-05-14
00810188323965HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188323972HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188322555HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810188322562HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810128537384HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2024-09-09
00810128531702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-08-08
00810128531795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-07-25
00810128530149HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810128530156HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810077249741HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-02-16
00810077249284HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-18
00810077248959HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-04
00810077247471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247488HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247518HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-08
00810077245828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-06-21
00810077245675HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-05-20
00810077244937HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-04-20
00810077243312HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-14
00810077242605HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-05
00810023928409HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2021-01-22
00810023927631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-11-09
00810023925477HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-06-23
00810023924920HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-04-30
00810023923589HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-02-24
00810023920984HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-20
00810023920854HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-15
00810042038486HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-03-21
00810042036857HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2018-12-03