Disposable Needle Guide 5480

by Protek Medical Products, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10841912106629 UDI-DI	Date1 Jun 2020Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Disposable Needle Guide
Generic Name: Needle guide, single-use
Model / Reference: 5480

Primary DI / UDI-DI: 10841912106629
510(k) Number: K971115
K971722
FDA Product Code: ITX
GMDN Term: Needle guide, single-use

Device Class: Class II
Regulation Number: 892.1570
GUDID distribution status: In Commercial Distribution

Other devices from Protek Medical Products, Inc.

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Sterile Disposable Endocavity Needle Guide Kit 5253

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Reusable Multi Angle Biospy Bracket 6158

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Biopsy Starter Kit 7138

Not classified
Sterile Disposable Endocavity Needle Guide Kit 5176

Class II

See all devices from Protek Medical Products, Inc. →

Properties

Single Use
Lot / Batch Number

Other properties (12)

Sterile: 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