AccessGUDID - DEVICE: SFAM (00850987007413)

GUDID

Device Identifier (DI) Information

Brand Name: SFAM
Version or Model: SFAM035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SFAM035
Company Name: SURGICAL TECHNOLOGY LABORATORIES INC

Primary DI Number: 00850987007413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080380106 *Terms of Use

Device Description: "SFAM035 ePTFE Flat Sheet (0.35mm)"

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33473	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021889	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a344282-1a74-478f-8573-f80e0ad1d3cf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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