Identity
- Trade Name
- Lone Star FDA UDI
- Generic Name
- Corpus cavernosum dilator, reusable FDA UDI
- Device Name
- Lone Star Dilamezinsert Inserter Disposable 12 mm Blue FDA UDI
- Model / Reference
- DMI-12G FDA UDI
- Description
- Lone Star Dilamezinsert Inserter Disposable 12 mm Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937018202 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Corpus cavernosum dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Corpus cavernosum dilator, reusable
Lone Star by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corpus cavernosum dilator, reusable.
- Rigicon Stainless Steel Dilator 11-12 mm — Rigicon, Inc. · Class I
- Brooks — Coloplast A/S · Class I
- RIGICON DILATOM™ — Rigicon, Inc. · Class I
- Furlow — Coloplast A/S · 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
- Rigicon HL-LEVINE Combo Prosthesis Tool - 10/12 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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 24f8348a-e4a1-464a-97c5-98f02ab94128 33 fields · synced Jun 9, 2026