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Panta® 519005ND

by Newdeal Sas

Panta® 519005ND is a Class I device made by Newdeal Sas, listed in FDA GUDID since 26 May 2017 (UDI-DI 10381780045557), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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 Number10381780045557 UDI-DI Date26 May 2017ListedStatusListed GUDID: 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  • Withdrawn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
Panta®
Generic name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
519005ND
Primary DI / UDI-DI
10381780045557
FDA product code
HTW
GMDN term
Fluted surgical drill bit, single-use
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)