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Posifix Overlay 108070

by Medtec LLC

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 Number00841439100431 UDI-DI Date2 Aug 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  • Withdrawn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
Posifix Overlay
Generic Name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
108070
Primary DI / UDI-DI
00841439100431
510(k) Number
FDA Product Code
IYE
GMDN Term
Indexed-immobilization patient positioning system
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
Not in Commercial Distribution
Size
Width — 21.81 Inch
Length — 39.25 Inch

Related devices

Cleared under the same submission (K060737)

Show all (12)

Other devices from Medtec LLC

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No