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MIRA IMEX Scleral Buckling Component
FDA UDIClass II (US FDA UDI)
by Mira, Inc.
Identity
- Trade Name
- MIRA IMEX Scleral Buckling Component FDA UDI
- Generic Name
- Scleral buckling device, non-bioabsorbable FDA UDI
- Device Name
- Strip 6mm FDA UDI
- Model / Reference
- 220 FDA UDI
- Description
- Strip 6mm FDA UDI
Identifiers
- Catalog Number
- 220 FDA UDI
- Primary DI / UDI-DI
- 10850510007122 FDA UDI
- 510(k) Number
- K950806 FDA UDI
- FDA Product Code
- HQX FDA UDI
- GMDN Term
- Scleral buckling device, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scleral buckling device, non-bioabsorbable
MIRA IMEX Scleral Buckling Component by Mira, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scleral buckling device, non-bioabsorbable.
- HALF-SPONGE 2.75 X 7.5 TYPE 511 — FCI S A S FCI 20 22 · Class II
- Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22 · Class II
- Scleral Buckling Product Style 505T, 5.0mm Round Tunel Sponge — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22 · Class II
- Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22 · Class II
- Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22 · Class II
- Scleral Buckling Products: Style 41, 3.5mm Silicone Strip — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22 · Class II
Cleared under the same submission
K950806 also covers:
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
- MIRA IMEX Scleral Buckling Component — MIRA, INC.
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
- Mira, Inc.
Sources (1)
- FDA UDI db73d628-ce6b-4260-9fb7-beb210cf8f42 37 fields · synced Jun 8, 2026