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Guidewire Locking Device

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name
Guidewire Locking Device FDA UDI
Generic Name
Endoscopic guidewire holder FDA UDI
Device Name
The Guidewire Locking Device is an accessory to be used with endoscopic devices to lock the wire guide(s) in place during ERCP procedures.For use with Pentax endoscope. FDA UDI
Model / Reference
MT-RGL-P FDA UDI
Description
The Guidewire Locking Device is an accessory to be used with endoscopic devices to lock the wire guide(s) in place during ERCP procedures.For use with Pentax endoscope. FDA UDI

Identifiers

Primary DI / UDI-DI
06932503562799 FDA UDI
510(k) Number
K220247 FDA UDI
FDA Product Code
ODC FDA UDI
GMDN Term
Endoscopic guidewire holder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic guidewire holder

Guidewire Locking Device by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic guidewire holder.

Cleared under the same submission

K220247 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

  • FDA UDI c135fbb8-eee4-4fb8-9dca-223254499f0f 35 fields · synced May 30, 2026