Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm

FDA UDI

Class I (US FDA UDI)

by Rigicon, Inc.

Identity

Trade Name: Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm FDA UDI
Generic Name: Corpus cavernosum dilator, reusable FDA UDI
Device Name: Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm FDA UDI
Model / Reference: RSSL-1012 FDA UDI
Description: Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm FDA UDI

Identifiers

Catalog Number: RSSL-1012 FDA UDI
Primary DI / UDI-DI: 00850033207453 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Gastro-urological director Corpus cavernosum dilator, reusable

Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 mm by Rigicon, Inc. — 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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RIGICON DILATOM™ — Rigicon, Inc. · Class I
RIGICON DILATOM™ — Rigicon, Inc. · Class I
Rigicon Stainless Steel Dilator 09-10 mm — Rigicon, Inc. · Class I
RIGICON DILATOM™ — 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: Rigicon, Inc.

Sources (1)

FDA UDI 6d620d92-1fce-48b9-9faf-ae48895bcda7 34 fields · synced Jun 7, 2026