Identity
- Trade Name
- Eye Shield FDA UDI
- Generic Name
- Radiation/mechanical corneal shield, reusable FDA UDI
- Device Name
- Eye Shield - Medium FDA UDI
- Model / Reference
- MTT45M FDA UDI
- Description
- Eye Shield - Medium FDA UDI
Identifiers
- Catalog Number
- MTT45M FDA UDI
- Primary DI / UDI-DI
- 00841439107775 FDA UDI
- 510(k) Number
- K945515 FDA UDI
- FDA Product Code
- IWS FDA UDI
- GMDN Term
- Radiation/mechanical corneal shield, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 1.06 Inch FDA UDIWidth — 1 Inch FDA UDI
Eye Shield by Medtec LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtec LLC
Sources (1)
- FDA UDI fd6e57c4-db1b-493b-b4d7-b4459180f2d3 38 fields · synced Jun 1, 2026