DEVICE: SFAM (00085198807990)

Device Identifier (DI) Information

SFAM
SFAM602
In Commercial Distribution
SFAM602
SURGICAL TECHNOLOGY LABORATORIES INC
00085198807990
GS1

1
080380106 *Terms of Use
SFAM ePTFE Block 10cm X 6cm
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
PTFE/carbon-fibre craniofacial tissue reconstructive material A 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K021889 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

a6a4a013-5584-449e-a8ff-52dc79068ae2
July 06, 2018
3
January 05, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE