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Belotero Balance Lidocaine 8718M0S

by Anteis SA

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 Number07640123793316 UDI-DI Date30 Sep 2025ListedStatusListed 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  • Withdrawn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
Belotero Balance Lidocaine
Generic Name
Dermal tissue reconstructive material, microbe-derived
Model / Reference
8718M0S
Primary DI / UDI-DI
07640123793316
PMA Number
FDA Product Code
LMH
GMDN Term
Dermal tissue reconstructive material, microbe-derived
Device Class
Class III
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter
Needle Gauge — 27 Gauge
Needle Gauge — 30 Gauge

Related devices

Cleared under the same submission (P090016)

Other devices from Anteis SA

Properties

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

Other properties (6)

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