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Sfam

FDA UDI

Class II (US FDA UDI)

by Surgical Technology Laboratories Inc.

Identity

Trade Name
SFAM FDA UDI
Generic Name
PTFE/carbon-fibre craniofacial tissue reconstructive material FDA UDI
Device Name
"ESH-7141 1mm ePTFE Sheet (7x14cm)" FDA UDI
Model / Reference
eSH-7141 FDA UDI
Description
"ESH-7141 1mm ePTFE Sheet (7x14cm)" FDA UDI

Identifiers

Catalog Number
eSH-7141 FDA UDI
Primary DI / UDI-DI
00850987007345 FDA UDI
510(k) Number
K021889 FDA UDI
FDA Product Code
KKY FDA UDI
GMDN Term
PTFE/carbon-fibre craniofacial tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: PTFE/carbon-fibre craniofacial tissue reconstructive material

Sfam by Surgical Technology Laboratories Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as PTFE/carbon-fibre craniofacial tissue reconstructive material.

Cleared under the same submission

K021889 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Technology Laboratories Inc.

Sources (1)

  • FDA UDI 8409fd06-7413-4479-92d6-d1075306f4c7 35 fields · synced Jun 1, 2026