← Back to catalogue

Gyrus ACMI

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Gyrus ACMI FDA UDI
Generic Name
Polymeric ureteral stent FDA UDI
Device Name
CLASSIC Open Tip Ureteral Stent 8.5 FR X 22 cm w/PTFE Coated Moveable Core Guidewire .038” X 150 cm FDA UDI
Model / Reference
5388220 FDA UDI
Description
CLASSIC Open Tip Ureteral Stent 8.5 FR X 22 cm w/PTFE Coated Moveable Core Guidewire .038” X 150 cm FDA UDI

Identifiers

Primary DI / UDI-DI
00821925005099 FDA UDI
510(k) Number
K781641 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

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

Cleared under the same submission

K781641 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI e06ab679-3c89-416b-a310-4ec3d37a2ece 35 fields · synced Jun 1, 2026