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Zaffiro IR Treatment Body Applicator ZIR

by Neauvia North America, 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 Number00850017374225 UDI-DI Date11 Feb 2026ListedStatusListed 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  • Withdrawn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
Zaffiro IR Treatment Body Applicator
Generic Name
Dermabrasion brush, rotary
Model / Ref / Catalog
ZIR, 300-1107
Primary DI / UDI-DI
00850017374225
FDA Product Code
GFE
GMDN Term
Dermabrasion brush, rotary
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No