Identity
- Trade Name
- SEEG DRILL ADAPTOR 2.70MM FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Seeg Drill Adaptor Ø2.70 mm instrument Rosa 3.1 (brain application) stainless steel instrument adaptor for drilling FDA UDI
- Model / Reference
- 174153 FDA UDI
- Description
- Seeg Drill Adaptor Ø2.70 mm instrument Rosa 3.1 (brain application) stainless steel instrument adaptor for drilling FDA UDI
Identifiers
- Catalog Number
- ROSAS00085 FDA UDI
- Primary DI / UDI-DI
- 00887868539978 FDA UDI
- 510(k) Number
- K231103 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- 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
MR Unsafe FDA UDI
Category: Multi-purpose stereotactic surgery system
Seeg Drill Adaptor 2.70mm by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-purpose stereotactic surgery system.
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Cleared under the same submission
K231103 also covers:
- ALLEN WRENCH 8MM — MEDTECH LLC
- CRW frame adaptor — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — MEDTECH LLC
- Optical distance sensor — MEDTECH LLC
- PLANNING STATION - ROSA ONE - USA — MEDTECH LLC
- PLANNING STATION - ROSA ONE - USA — MEDTECH LLC
- ROSA ONE BRAIN APPLICATION (US) — MEDTECH LLC
- Radiolucent support arm — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3, 9 mm — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5, 1 mm — MEDTECH LLC
- Trnsnsl Endscp Ovoid Ø6.18mm Holder — MEDTECH LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtech Llc
Sources (1)
- FDA UDI 6c23abd5-011d-4561-8c0e-d9d98e9a000d 36 fields · synced May 30, 2026