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Shoulder Innovations InSet 135 Instrument Case/Tray

by SHOULDER INNOVATIONS, 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 NumberB1132L2HB000020 UDI-DI Date12 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
InSet 135 Instrument Case/Tray, 2L2HB00002
Primary DI / UDI-DI
B1132L2HB000020
FDA Product Code
KWT, PHX, MBX, KWS, HSD
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class II
Regulation Number
888.3650, 888.3660, 888.3690
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (11)

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