Rigicon Dilatom™

FDA UDIEUDAMED

Class I (US FDA UDI)

by Rigicon, Inc.

Identity

Trade Name: RIGICON DILATOM™ FDA UDI
Generic Name: Corpus cavernosum dilator, reusable FDA UDI
Model / Reference: 13-14 MM FDA UDI

Identifiers

Catalog Number: RSSC-1314 FDA UDI
Primary DI / UDI-DI: 00850033207842 FDA UDI
FDA Product Code: QGA FDA UDI
GMDN Term: Corpus cavernosum dilator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.3500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Corpus cavernosum dilator, reusable

Rigicon Dilatom™ by Rigicon, Inc. — Class I — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Corpus cavernosum dilator, reusable.

Brooks — Coloplast A/S · Class I
Furlow — Coloplast A/S · Class I
Lone Star — CooperSurgical, Inc. · Class I
Rigicon Stainless Steel Dilator 11-12 mm — Rigicon, Inc. · Class I
RIGICON DILATOM™ — Rigicon, Inc. · Class I
RIGICON DILATOM™ — Rigicon, Inc. · Class I
Rigicon Stainless Steel Dilator 09-10 mm — Rigicon, Inc. · Class I
Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm — Rigicon, Inc. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class I	Unknown
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Rigicon, Inc.

Sources (2)

FDA UDI ce83d24f-03e8-473f-87e0-720d876844bc 33 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026