Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, sterile FDA UDI
- Device Name
- Camera Cover FDA UDI
- Model / Reference
- 5700536 FDA UDI
- Description
- Camera Cover FDA UDI
Identifiers
- Catalog Number
- 5700536 FDA UDI
- Primary DI / UDI-DI
- 10304040040635 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, sterile 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cable/lead/sensor/probe cover, sterile
Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cable/lead/sensor/probe cover, sterile.
- TRUWAVE — Edwards Lifesciences LLC · Class II
- Sterimed — Sterimed, Inc. · Class II
- TRUWAVE — Edwards Lifesciences LLC · Class II
- Sterimed — Sterimed, Inc. · Class II
- DEXcam3™ intra-oral camera sheaths — DEXIS LLC · Class I
- Hygienic Sleeves 3D Bite Block — Carestream Dental LLC · Class I
- Probe Cover Kits — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Hygienic Sleeves Bite Block — CARESTREAM HEALTH, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (1)
- FDA UDI 7e2ce464-9d1b-456c-bb50-d0588d4a47cf 34 fields · synced May 31, 2026