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B-Bop Bbopset

by Newdeal Sas

B-Bop Bbopset is a Class II device made by Newdeal Sas, listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780064381), 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 Number10381780064381 UDI-DI Date9 Oct 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  • Withdrawn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
B-Bop
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
BBOPSET
Primary DI / UDI-DI
10381780064381
FDA product code
HRS, HTY
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3030, 888.3040
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
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Serial number
Other properties (9, all answered No)