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JAZZ System Straight Passer-30mm

by Implanet 2 variants

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 Number03607505503509 UDI-DI Date21 Mar 2019ListedStatusListed 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  • Withdrawn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
JAZZ System
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
Straight Passer-30mm, 550350
Primary DI / UDI-DI
03607505503509
510(k) Number
FDA Product Code
OWI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class II
Regulation Number
888.3010
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Category: Orthopaedic surgical procedure kit, non-medicated, reusable

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Cleared under the same submission (K191217)

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Properties

  • Lot / Batch Number

Other properties (13)

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