Identity
- Trade Name
- Hygienic Sleeves Ear Cones FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, sterile FDA UDI
- Device Name
- SINGLE USE SLEEVES - EAR RODS FDA UDI
- Model / Reference
- Hygienic Sleeves Ear Cones FDA UDI
- Description
- SINGLE USE SLEEVES - EAR RODS FDA UDI
Identifiers
- Catalog Number
- 5302898 FDA UDI
- Primary DI / UDI-DI
- 60889975302898 FDA UDI
- FDA Product Code
- KQM FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 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
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
Category: Cable/lead/sensor/probe cover, sterile
Hygienic Sleeves Ear Cones by Carestream Health, Inc. — Class I — 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
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- Hygienic Sleeves 3D Bite Block — Carestream Dental LLC · Class I
- Probe Cover Kits — PROTEK MEDICAL PRODUCTS, INC. · Class II
- DEXcam4™ Intra-oral camera sheaths — DEXIS LLC · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Carestream Health, Inc.
Sources (1)
- FDA UDI 76f2cc6f-c9b2-448d-80c0-f3cd189bc19d 34 fields · synced Jun 8, 2026