Identity
- Trade Name
- IOPS® FDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Device Name
- IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure. FDA UDI
- Model / Reference
- T02111 FDA UDI
- Description
- IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure. FDA UDI
Identifiers
- Catalog Number
- T02111 FDA UDI
- Primary DI / UDI-DI
- 00843152103027 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Electromagnetic surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electromagnetic surgical navigation device tracking system
Iops® by Centerline Biomedical — 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
- Centerline Biomedical
Sources (1)
- FDA UDI 4509a753-5f27-4739-b889-57ec0bea6aa0 34 fields · synced May 30, 2026