Identity
- Trade Name
- miniRUMEL™ FDA UDI
- Generic Name
- Suture/ligature tightener, single-use FDA UDI
- Device Name
- miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device. FDA UDI
- Model / Reference
- 080130 FDA UDI
- Description
- miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device. FDA UDI
Identifiers
- Catalog Number
- 080130 FDA UDI
- Primary DI / UDI-DI
- 00850200006582 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Suture/ligature tightener, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Inch FDA UDI
miniRUMEL™ by LSI Solutions, 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 |
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Manufacturer
- Manufacturer
- LSI Solutions, Inc.
Sources (1)
- FDA UDI b6f875de-bbf8-4069-8df5-4cfc8d7c1f08 37 fields · synced May 30, 2026