Identity
- Trade Name
- Sterimed FDA UDI
- Generic Name
- Camera cover, single-use FDA UDI
- Device Name
- Video Camera/Laser Arm Cover with Perforations 9" X 80" FDA UDI
- Model / Reference
- VC0980P FDA UDI
- Description
- Video Camera/Laser Arm Cover with Perforations 9" X 80" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850341007561 FDA UDI
- 510(k) Number
- K853044 FDA UDI
- FDA Product Code
- IZI FDA UDI
- GMDN Term
- Camera cover, single-use 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: Camera cover, single-use
Sterimed by Sterimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Camera cover, single-use.
- MICROTEK — Microtek Medical LLC · Class II
- Camera sleeve — PURPLE SURGICAL INTERNATIONAL LIMITED · Class I
- MICROTEK — Microtek Medical LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- MICROTEK — Microtek Medical LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
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 6d5cc237-1110-4fe4-a887-0a1eb86ce768 35 fields · synced May 30, 2026