Identity
- Trade Name
- Shell, Scleral FDA UDI
- Generic Name
- Scleral shell FDA UDI
- Model / Reference
- V2627 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B796V2627 FDA UDI
- FDA Product Code
- HQT FDA UDI
- GMDN Term
- Scleral shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3800 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scleral shell
Shell, Scleral by Midwest Eye Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scleral shell.
- Shell, Scleral — MIDWEST EYE LABORATORIES WOODBURY LLC · Class II
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- Scleral Shell — TEXAS EYE PROSTHETICS LLC · Class II
- Scleral Shell — Legrand Associates · Class II
- Scleral Shell — THE EYE CONCERN, INC. · Class II
- Shell, Scleral — MIDWEST EYE LABORATORIES SIOUX FALLS LLC · Class II
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
- Midwest Eye Laboratories, Inc.
Sources (1)
- FDA UDI 033e86fc-c87f-458e-a9d2-ffad44343509 32 fields · synced Sep 18, 2026