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BellaFractora24C Tip NG604108D

by Inbella Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00850055552050 UDI-DI Date30 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BellaFractora24C Tip
Generic Name
Radio-frequency skin contouring system applicator tip
Model / Reference
NG604108D
Primary DI / UDI-DI
00850055552050
510(k) Number
FDA Product Code
GEI
GMDN Term
Radio-frequency skin contouring system applicator tip
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilization Method
Dry Heat Sterilization

Related devices

Cleared under the same submission (K252367)

Show all (12)

Other devices from Inbella Medical, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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