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SXono Green Uni Sterile Disposable Endocavity Needle Guide 5145

by Protek Medical Products, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841912104529 UDI-DI Date16 Sep 2016ListedStatusListed 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  • Withdrawn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
SXono Green Uni Sterile Disposable Endocavity Needle Guide
Generic Name
Needle guide, single-use
Model / Ref / Catalog
5145, SXono-S-10
Primary DI / UDI-DI
00841912104529
FDA Product Code
ITX
GMDN Term
Needle guide, single-use
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Needle guide, single-use

Other devices from Protek Medical Products, Inc.

See all devices from Protek Medical Products, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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