Identity
- Trade Name
- Golden Isles Pedicle Screw System FDA UDI
- Generic Name
- Microplate seal roller IVD FDA UDI
- Device Name
- Curved Titanium Rod FDA UDI
- Model / Reference
- C25-2000-060 FDA UDI
- Description
- Curved Titanium Rod FDA UDI
Identifiers
- Primary DI / UDI-DI
- G079C2520000600 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Microplate seal roller IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDI
Category: Microplate seal roller IVD
Golden Isles Pedicle Screw System by Intelivation, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microplate seal roller IVD.
- ZAVATION — ZAVATION · Class II
- ARx — Life Spine, Inc. · Class II
- m2000 — Abbott Molecular · Class I
- ARx — Life Spine, Inc. · Class II
- ZAVATION — ZAVATION · Class II
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
- Intelivation, LLC
Sources (1)
- FDA UDI 9bf25240-c134-442f-a550-726dc91272c8 35 fields · synced May 30, 2026