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Sorrento Bioglass 10cc (100 x 20 x 5 mm) HB-118-0010

by Xenco Medical LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB064HB1180010 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sorrento Bioglass 10cc (100 x 20 x 5 mm)
Generic Name
Orthopaedic bone void filling material, animal-derived, bioabsorbable
Model / Reference
HB-118-0010
Primary DI / UDI-DI
B064HB1180010
510(k) Number
FDA Product Code
MQV
GMDN Term
Orthopaedic bone void filling material, animal-derived, bioabsorbable
Device Class
Class II
Regulation Number
888.3045
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K173933)

Other devices from Xenco Medical LLC

See all devices from Xenco Medical LLC →

Properties

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

Other properties (9)

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