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Oral Surgery Pack 12.S8318.00

by Omnia Spa GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08056646500482 UDI-DIDate27 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Oral Surgery Pack
Generic Name
General surgical procedure kit, non-medicated, single-use
Model / Reference
12.S8318.00
Primary DI / UDI-DI
08056646500482
510(k) Number
FDA Product Code
KKX
GMDN Term
General surgical procedure kit, non-medicated, single-use
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K110724)

Show all (9)

Other devices from Omnia Spa

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No