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Perma Facial Implant PFI 3065

by Surgisil, LLP

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853437006028 UDI-DI Date16 Nov 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Perma Facial Implant
Generic Name
Lip prosthesis
Model / Reference
PFI 3065
Primary DI / UDI-DI
00853437006028
510(k) Number
FDA Product Code
ODU
GMDN Term
Lip prosthesis
Device Class
Class II
Regulation Number
878.3500
GUDID distribution status
Not in Commercial Distribution
Size
Length — 65 Millimeter
Outer Diameter — 3 Millimeter

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No