Identity
- Trade Name
- ORLocate FDA UDI
- Generic Name
- Radiopaque woven surgical sponge FDA UDI
- Device Name
- OrLocate HoveRead is used with th ORLocate Sponge Solution System. FDA UDI
- Model / Reference
- ORLocate HoveRead FDA UDI
- Description
- OrLocate HoveRead is used with th ORLocate Sponge Solution System. FDA UDI
Identifiers
- Catalog Number
- OX201 FDA UDI
- Primary DI / UDI-DI
- 00724995243630 FDA UDI
- 510(k) Number
- K100551 FDA UDI
- FDA Product Code
- LWH FDA UDI
- GMDN Term
- Radiopaque woven surgical sponge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2740 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
No
FDA UDI
Category: Radiopaque woven surgical sponge
ORLocate by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiopaque woven surgical sponge.
- SurgiCount Safety-Sponge — Stryker Corp. · Class I
- DuLap® — Derma Sciences Canada, Inc · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Kerlix — Cardinalhealth · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- AMD-RITMED — AMD Medicom Inc · Class I
- Dukal — Dukal LLC · Class I
- HCS — DYAD MEDICAL SOURCING, LLC · Class I
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Steris Corporation
Sources (1)
- FDA UDI 813300e3-91d3-4eed-9809-ed43fd6a4a02 36 fields · synced Jun 8, 2026