RetroFit Sterile Disposable Needle Guide 5300

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 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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841912103355 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: RetroFit Sterile Disposable Needle Guide
Generic Name: Body-surface ultrasound imaging transducer cover
Model / Reference: 5300

Primary DI / UDI-DI: 00841912103355
510(k) Number: K970893
K973958
FDA Product Code: KKX, ITX
GMDN Term: Body-surface ultrasound imaging transducer cover

Device Class: Class II
Regulation Number: 878.4370, 892.1570
GUDID distribution status: In Commercial Distribution

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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
Prescription Use

Other properties (12)

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