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Insite 0846832000432

by Tornier, Inc.

Insite 0846832000432 is a Class I device made by Tornier, Inc., listed in FDA GUDID since 2 Dec 2022 (UDI-DI 00846832000432), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846832000432 UDI-DI Date2 Dec 2022ListedStatusListed 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  • Withdrawn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
Insite
Generic name
Bone tap, reusable
Model / Ref / Catalog
0846832000432
Primary DI / UDI-DI
00846832000432
FDA product code
HWX
GMDN term
Bone tap, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 6.5 Millimeter

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)