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Calcanea™ 129130ND

by Newdeal Sas

Calcanea™ 129130ND is a Class I device made by Newdeal Sas, listed in FDA GUDID since 26 May 2017 (UDI-DI 10381780042983), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780042983 UDI-DI Date26 May 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Calcanea™
Generic name
Surgical drill guide, reusable
Model / reference
129130ND
Primary DI / UDI-DI
10381780042983
FDA product code
FZX
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)