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Blue Sky Bio, LLC. 5.1

by Blue Sky Bio LLC

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

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 Number00810060227053 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Blue Sky Bio, LLC.
Generic Name
Dental treatment application software
Model / Ref / Catalog
5.1, BSP
Primary DI / UDI-DI
00810060227053
FDA Product Code
NXC, PZY, DYW, NOF, PNN, LLZ
GMDN Term
Dental treatment application software
Device Class
Class II
Regulation Number
872.5470, 872.3590, 872.3661, 892.2050
GUDID distribution status
In Commercial Distribution

Other devices from Blue Sky Bio LLC

See all devices from Blue Sky Bio LLC →

Properties

  • Prescription Use

Other properties (13)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No