Identity
- Trade Name
- ORLocate FDA UDI
- Generic Name
- Radio-frequency identification reader FDA UDI
- Device Name
- ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solution System. FDA UDI
- Model / Reference
- ORLocate Drape FDA UDI
- Description
- ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solution System. FDA UDI
Identifiers
- Catalog Number
- HC12631NS FDA UDI
- Primary DI / UDI-DI
- 10724995221635 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Radio-frequency identification reader FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Radio-frequency identification reader
ORLocate by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Smart Caregiver — Smart Caregiver Corporation · Class I
- SCOPE ID TAG — Olympus Medical Systems Corporation · 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
- Steris Corporation
Sources (1)
- FDA UDI 7e3689ff-1398-4681-b8f2-a1a9f601c474 35 fields · synced Jun 8, 2026