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Rigicon Stainless Steel Dilator 10-12 mm

FDA UDI

Class I (US FDA UDI)

by Rigicon, Inc.

Identity

Trade Name
Rigicon Stainless Steel Dilator 10-12 mm FDA UDI
Generic Name
Corpus cavernosum dilator, reusable FDA UDI
Device Name
Rigicon Stainless Steel Dilator 10-12 mm FDA UDI
Model / Reference
RSSD-1012 FDA UDI
Description
Rigicon Stainless Steel Dilator 10-12 mm FDA UDI

Identifiers

Catalog Number
RSSD-1012 FDA UDI
Primary DI / UDI-DI
00850015358326 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Corpus cavernosum dilator, reusable

Rigicon Stainless Steel Dilator 10-12 mm by Rigicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Corpus cavernosum dilator, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rigicon, Inc.

Sources (1)

  • FDA UDI e5d3645c-6fcf-4519-8dd2-dad30a54d765 34 fields · synced May 30, 2026