Identity
- Trade Name
- Blinkeze FDA UDI
- Generic Name
- Eyelid weight, external FDA UDI
- Device Name
- Blinkeze External Lid Weight, 1.4g, Tan FDA UDI
- Model / Reference
- TEW6014-2 FDA UDI
- Description
- Blinkeze External Lid Weight, 1.4g, Tan FDA UDI
Identifiers
- Catalog Number
- TEW6014-2 FDA UDI
- Primary DI / UDI-DI
- 00813142021327 FDA UDI
- 510(k) Number
- K940974 FDA UDI
- FDA Product Code
- MML FDA UDI
- GMDN Term
- Eyelid weight, external FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5700 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Eyelid weight, external
Blinkeze by Meddev Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eyelid weight, external.
- EXTERNAL OCULID TAN® - 1, 0 g — FCI S A S FCI 20 22 · Class II
- EXTERNAL OCULID DARK BROWN® - 1, 4 g — FCI S A S FCI 20 22 · Class II
- EXTERNAL OCULID MEDIUM BROWN® - 1, 0 g — FCI S A S FCI 20 22 · Class II
- EXTERNAL OCULID LIGHT® - 0, 6 g — FCI S A S FCI 20 22 · Class II
- EXTERNAL OCULID TAN® - 1, 4 g — FCI S A S FCI 20 22 · Class II
- 7 EXTERNAL EYELID WEIGHTS SIZING SET — FCI S A S FCI 20 22 · Class II
- EXTERNAL OCULID DARK BROWN® - 1, 6 g — FCI S A S FCI 20 22 · Class II
- EXTERNAL OCULID PINK® - 0, 8 g — FCI S A S FCI 20 22 · Class II
Cleared under the same submission
K940974 also covers:
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
- Blinkeze — MEDDEV CORPORATION
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
- Meddev Corporation
Sources (1)
- FDA UDI 76b88467-04ae-40ca-83d5-f289fa6d2f25 35 fields · synced Jun 1, 2026