Identity
- Trade Name
- ROMEO 2 INSTRUMENTATION FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- DILATOR TUBE 4 PUSHER FDA UDI
- Model / Reference
- MIS-IN 06 06-N FDA UDI
- Description
- DILATOR TUBE 4 PUSHER FDA UDI
Identifiers
- Catalog Number
- MIS-IN 06 06-N FDA UDI
- Primary DI / UDI-DI
- 07640151084271 FDA UDI
- FDA Product Code
- KWP FDA UDIMNH FDA UDIMNI FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument handle, non-torque-limiting
The ROMEO 2 INSTRUMENTATION is a versatile, non-torque-limiting surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) for manual manipulation. This reusable device is made of metal and/or synthetic material with a straight or T-shaped handle grip that may include additional features like a ratchet mechanism.
Similar devices
Also classified as Surgical instrument handle, non-torque-limiting.
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- Equinoxe — Exactech, Inc. · Class II
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- CUSTOM U JOINT DRIVER — Zimmer, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA UDI 7fcc101e-e7bd-4f99-a7a0-2d253b101616 34 fields · synced Jun 20, 2026