Brooks

FDA UDI

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name: Brooks FDA UDI
Generic Name: Corpus cavernosum dilator, reusable FDA UDI
Model / Reference: 91-9350 FDA UDI

Identifiers

Catalog Number: 91-9350 FDA UDI
Primary DI / UDI-DI: 05708932627320 FDA UDI
FDA Product Code: KOA FDA UDI
GMDN Term: Corpus cavernosum dilator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Corpus cavernosum dilator, reusable

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

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Also classified as Corpus cavernosum dilator, reusable.

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Lone Star — CooperSurgical, Inc. · Class I
Rigicon Stainless Steel Dilator 09-10 mm — Rigicon, Inc. · Class I
RIGICON DILATOM™ — Rigicon, Inc. · Class I
Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm — Rigicon, Inc. · Class I
Rigicon Stainless Steel Dilator 13-14 mm — Rigicon, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Coloplast A/S

Sources (1)

FDA UDI 8f86f38e-c5eb-4970-9305-90b8fc62d5ba 34 fields · synced May 30, 2026