Identity
- Trade Name
- Rigicon HL Dilator 09 – 10 mm FDA UDI
- Generic Name
- Penile prosthesis implantation instrument FDA UDI
- Device Name
- Rigicon HL Dilator 09 – 10 mm Disposable FDA UDI
- Model / Reference
- RSUD-0910 FDA UDI
- Description
- Rigicon HL Dilator 09 – 10 mm Disposable FDA UDI
Identifiers
- Catalog Number
- RSUD-0910 FDA UDI
- Primary DI / UDI-DI
- 00850015358401 FDA UDI
- FDA Product Code
- KOA FDA UDI
- GMDN Term
- Penile prosthesis implantation instrument 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Penile prosthesis implantation instrument
Rigicon HL Dilator 09 – 10 mm by Rigicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Penile prosthesis implantation instrument.
- Rigicon HL Dilator 15 – 16 mm — Rigicon, Inc. · Class I
- Rigicon Furlow Insertion Tool — 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 e55195f5-8143-4e9d-bc6b-6319ff481a10 34 fields · synced May 31, 2026