Identity
- Trade Name
- Two-Piece Slotted Cannula Kit FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Model / Reference
- 2SCK1-190X FDA UDI
Identifiers
- Catalog Number
- 2SCK1-190X FDA UDI
- Primary DI / UDI-DI
- 00841823100061 FDA UDI
- FDA Product Code
- GEA FDA UDI
- GMDN Term
- Neurological stereotactic surgery system 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurological stereotactic surgery system
Two-Piece Slotted Cannula Kit by Ad-Tech Medical Instrument Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ad-Tech Medical Instrument Corp.
Sources (1)
- FDA UDI 8c48f87c-0508-48c0-8c11-6b245f165bca 35 fields · synced Jun 9, 2026