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Scleral Buckling Products: Style 279, Concave Tire
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Scleral Buckling Products: Style 279, Concave Tire FDA UDI
- Generic Name
- Scleral buckling device, non-bioabsorbable FDA UDI
- Model / Reference
- 92-16 FDA UDI
Identifiers
- Catalog Number
- 92-16 FDA UDI
- Primary DI / UDI-DI
- 08717872014388 FDA UDI
- 510(k) Number
- K023481 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scleral buckling device, non-bioabsorbable
Scleral Buckling Products: Style 279, Concave Tire by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Scleral buckling device, non-bioabsorbable.
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- Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22 · Class II
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- MIRA IMEX Scleral Buckling Component — MIRA, INC. · Class II
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- Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22 · Class II
Cleared under the same submission
K023481 also covers:
- Scleral Buckling Product Style 505T, 5.0mm Round Tunel Sponge — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved Sponge — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 112, Meridional Implant – 12.0mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 137, 2.5mm Silicone Wedge — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 20, 2.0mm Grooved Strip — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 219, 2.5mm Grooved Strip — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 220, 2.5mm Grooved Strip — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 225, 2.5mm Grooved Strip — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 240, 2.5mm Circling Band — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 270, Silicone Sleeve — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 275, Asymmetrical Tire — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Scleral Buckling Products: Style 276, Asymmetrical Tire — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
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
Sources (1)
- FDA UDI 48220fba-c011-4787-8869-e8d5368425ab 34 fields · synced May 30, 2026