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Native Root 501.000

by Riverpoint Medical LLC

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 Number00840277411112 UDI-DI Date6 May 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  • Withdrawn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
Native Root
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use
Model / Reference
501.000
Primary DI / UDI-DI
00840277411112
FDA Product Code
OJH
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Riverpoint Medical LLC

See all devices from Riverpoint Medical LLC →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No