Identity
- Trade Name
- PASS OCT FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- PEDICLE SCREW Ø4 mm x 30 mm FDA UDI
- Model / Reference
- B17314030 FDA UDI
- Description
- PEDICLE SCREW Ø4 mm x 30 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03613720229452 FDA UDI
- FDA Product Code
- NKG FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3075 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
A comprehensive medical device directory, providing detailed information about the PASS OCT device. This PEDICLE SCREW Ø4 mm x 30 mm device is designed for spinal segment immobilization and stabilization in treatment of various spinal instabilities or deformities.
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
- Medicrea International SA
Sources (1)
- FDA UDI 84a2d028-66fb-40be-a99f-4b1c8f2bab2f 34 fields · synced Jul 12, 2026