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Iris

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
IRIS FDA UDI
Generic Name
Ureteral transilluminator, single-use FDA UDI
Device Name
[Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 370 cm Length, Do not use if package is damaged] FDA UDI
Model / Reference
0220180518 FDA UDI
Description
[Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 370 cm Length, Do not use if package is damaged] FDA UDI

Identifiers

Catalog Number
0220180518 FDA UDI
Primary DI / UDI-DI
07613327174816 FDA UDI
510(k) Number
K151243 FDA UDI
FDA Product Code
FCW FDA UDI
FCS FDA UDI
GMDN Term
Ureteral transilluminator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
876.4020 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: Ureteral transilluminator, single-use

Iris by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ureteral transilluminator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 6444a0fd-a4dd-43dc-bb3c-25679bb7c6d2 36 fields · synced Jun 8, 2026