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Offset Tip SP 9570860

by Mc Bio SRL

Offset Tip SP 9570860 is a Class I device made by Mc Bio SRL, listed in FDA GUDID since 23 Jun 2025 (UDI-DI 08057639710598), 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 Number08057639710598 UDI-DI Date23 Jun 2025ListedStatusListed 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  • Withdrawn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
Offset Tip SP
Generic name
Bone tack inserter, basic
Model / reference
9570860
Primary DI / UDI-DI
08057639710598
FDA product code
EJB
GMDN term
Bone tack inserter, basic
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone tack inserter, basic

Similar devices

Other devices filed under FDA product code EJB (Handle, Instrument, Dental).

Other devices from Mc Bio SRL

See all devices from Mc Bio SRL →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)