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Irr-080-6f

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
IRR-080-6F FDA UDI
Generic Name
Irrigation catheter, single-lumen FDA UDI
Device Name
Irrigation Catheter FDA UDI
Model / Reference
IRR-080-6F FDA UDI
Description
Irrigation Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00607915118259 FDA UDI
FDA Product Code
GCA FDA UDI
DQY FDA UDI
GMDN Term
Irrigation catheter, single-lumen FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
870.1250 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

Dimensions & Sizes

Size
Length — 80 Centimeter FDA UDI
Catheter Gauge — 6 French FDA UDI

Category: Irrigation catheter, single-lumen

Irr-080-6f by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Irrigation catheter, single-lumen.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA UDI 19ee9e17-f927-466f-ae60-c0d0d482d3da 35 fields · synced May 31, 2026