Identity
- Trade Name
- ENVISION 3D: PEDICLE PROBE FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker connector FDA UDI
- Model / Reference
- 11-0002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627843746638 FDA UDI
- FDA Product Code
- OLO 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical optical-tracking spatial marker connector
Envision 3d: Pedicle Probe by 7D Surgical ULC — 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
- 7D Surgical ULC
Sources (1)
- FDA UDI 00f16f7e-777c-499e-8ffc-3013fc21cba8 32 fields · synced Jun 6, 2026