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Hygitech Hy-98212

by Hygitech

Hygitech Hy-98212 is a Class I device made by Hygitech, listed in FDA GUDID since 16 Dec 2020 (UDI-DI 03615140005395), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03615140005395 UDI-DI Date16 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Hygitech
Generic name
Bone cutter
Model / Ref / Catalog
HY-98212
Primary DI / UDI-DI
03615140005395
FDA product code
EJB
GMDN term
Bone cutter
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone cutter

Similar devices

Other devices filed under FDA product code EJB (Handle, Instrument, Dental).

Other devices from Hygitech

See all devices from Hygitech →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)