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Porges Coloplast

FDA UDI

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Porges Coloplast FDA UDI
Generic Name
Nephrostomy catheter introduction needle FDA UDI
Device Name
Chiba puncture needles percutaneous nephrostomy set, 18G (ø 1.3 mm), 20 cm, Stainless steel FDA UDI
Model / Reference
RAC018 FDA UDI
Description
Chiba puncture needles percutaneous nephrostomy set, 18G (ø 1.3 mm), 20 cm, Stainless steel FDA UDI

Identifiers

Catalog Number
RAC018 FDA UDI
Primary DI / UDI-DI
05708932730150 FDA UDI
FDA Product Code
GBO FDA UDI
GMDN Term
Nephrostomy catheter introduction needle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

Yes

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 — 20 Centimeter FDA UDI
Needle Gauge — 18 Gauge FDA UDI

Category: Nephrostomy catheter introduction needle

Porges Coloplast by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nephrostomy catheter introduction needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 9624a82a-834e-4f5a-9d2f-631523c7f78a 37 fields · synced May 31, 2026