Identity
- Trade Name
- Sterimed FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, sterile FDA UDI
- Device Name
- Probe Cover 7" X 96" FDA UDI
- Model / Reference
- PC0796 FDA UDI
- Description
- Probe Cover 7" X 96" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850341007424 FDA UDI
- 510(k) Number
- K853044 FDA UDI
- FDA Product Code
- IZI FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1600 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Cable/lead/sensor/probe cover, sterile
Sterimed by Sterimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cable/lead/sensor/probe cover, sterile.
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Cleared under the same submission
K853044 also covers:
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
- Sterimed — Sterimed, Inc.
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
- Sterimed, Inc.
Sources (1)
- FDA UDI 687f52aa-1d9e-46cc-a646-b921e98fde7f 35 fields · synced May 31, 2026