Identity
- Trade Name
- Lone Star FDA UDI
- Generic Name
- Corpus cavernosum dilator, reusable FDA UDI
- Device Name
- Lone Star Dilamezinsert Tool; Stainless steel; sharp FDA UDI
- Model / Reference
- DMI-G FDA UDI
- Description
- Lone Star Dilamezinsert Tool; Stainless steel; sharp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937018226 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
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lone Star by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 9951bc98-05c2-48e5-b166-d21feeeb5fbb 34 fields · synced Jun 9, 2026