Skip to content

Sterile Disposable Endocavity Needle Guide Kit 5280

by Protek Medical Products, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00841912104659 UDI-DI Date16 Dec 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Sterile Disposable Endocavity Needle Guide Kit
Generic Name
Needle guide, single-use
Model / Reference
5280
Primary DI / UDI-DI
00841912104659
510(k) Number
FDA Product Code
ITX
GMDN Term
Needle guide, single-use
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K971115)

Show all (12)

Cleared under the same submission (K971722)

Show all (12)

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