Identity
- Trade Name
- Instrument clamp forceps FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker connector FDA UDI
- Device Name
- The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM. Instrument clamps are provided non-sterile and are intended to be sterilized by the user. Instrument clamps are reusable. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM. Instrument clamps are provided non-sterile and are intended to be sterilized by the user. Instrument clamps are reusable. FDA UDI
Identifiers
- Catalog Number
- U1 017 02 FDA UDI
- Primary DI / UDI-DI
- B057U1017020 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- Surgical optical-tracking spatial marker connector 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical optical-tracking spatial marker connector
Instrument clamp forceps by Scopis GmbH — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Scopis GmbH
Sources (1)
- FDA UDI 5bb4d61c-78ae-49a5-9f58-2fd513d1a533 34 fields · synced Jun 8, 2026