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Amplatz

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Amplatz FDA UDI
Generic Name
Polymeric ureteral stent FDA UDI
Device Name
Amplatz Ureteral Stent Set Ultrathane FDA UDI
Model / Reference
G09715 FDA UDI
Description
Amplatz Ureteral Stent Set Ultrathane FDA UDI

Identifiers

Catalog Number
UTSSW-10.2-28-AMP-RH FDA UDI
Primary DI / UDI-DI
00827002097155 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

Yes

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Polymeric ureteral stent

Amplatz by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric ureteral stent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 20e52a48-7b1c-488a-84b9-d1c35a2a83db 36 fields · synced Jun 8, 2026