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Coloplast

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Coloplast FDA UDI
Generic Name
Endoscopic-access dilator, single-use FDA UDI
Model / Reference
RBD014 FDA UDI

Identifiers

Catalog Number
RBD014 FDA UDI
Primary DI / UDI-DI
03600040975343 FDA UDI
FDA Product Code
EZN FDA UDI
GMDN Term
Endoscopic-access dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5470 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
Catheter Gauge — 14 French FDA UDI
Catheter Gauge — 12 French FDA UDI

Category: Endoscopic-access dilator, single-use

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

Similar devices

Also classified as Endoscopic-access dilator, single-use.

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 058b3c3e-4b31-4b64-8d75-c3f218109202 36 fields · synced May 30, 2026