Skip to content

BonVie+ EPBV-10ML

by Elute, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00199284455788 UDI-DIDate13 Aug 2025ListedStatusListed 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  • Withdrawn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
BonVie+
Generic Name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
EPBV-10ML
Primary DI / UDI-DI
00199284455788
510(k) Number
FDA Product Code
MQV
GMDN Term
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Device Class
Class II
Regulation Number
888.3045
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Total Volume — 10 Milliliter

Related devices

Category: Bone matrix implant, synthetic, non-antimicrobial

Other devices from Elute, Inc.

  • BonVie+

    Class II

  • EP Granules™ BVF

    Class II

Properties

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

Other properties (7)

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