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Multi-Flex

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
MULTI-FLEX FDA UDI
Generic Name
Polymeric ureteral stent FDA UDI
Device Name
MULTI-FLEX Open Tip Ureteral Stent 7.0 FR X 28 cm w/PTFE Moveable Core Guidewire .038" X 150 cm w/5 FR Open-End Ureteral Catheter FDA UDI
Model / Reference
5477280 FDA UDI
Description
MULTI-FLEX Open Tip Ureteral Stent 7.0 FR X 28 cm w/PTFE Moveable Core Guidewire .038" X 150 cm w/5 FR Open-End Ureteral Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00821925001107 FDA UDI
510(k) Number
K930733 FDA UDI
FDA Product Code
FAD FDA UDI
GMDN Term
Polymeric ureteral stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4620 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Multi-Flex by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K930733 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 3feb7520-c920-4360-ae51-e6bf8dc10dfd 35 fields · synced May 29, 2026