Identity
- Trade Name
- Round Sponge 5mm FDA UDI
- Generic Name
- Scleral buckling device, bioabsorbable FDA UDI
- Model / Reference
- S 1982-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10871321001277 FDA UDI
- 510(k) Number
- K875014 FDA UDI
- FDA Product Code
- HQJ FDA UDI
- GMDN Term
- Scleral buckling device, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3300 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
Yes
FDA UDI
MR Safe FDA UDI
Category: Scleral buckling device, bioabsorbable
Round Sponge 5mm by Labtician Ophthalmics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scleral buckling device, bioabsorbable.
- Pad — Labtician Ophthalmics, Inc · Class II
- Partial Thickness Sponge — Labtician Ophthalmics, Inc · Class II
- Scholda Partial Thickness — Labtician Ophthalmics, Inc · Class II
- Silicone Tire 10mm — Labtician Ophthalmics, Inc · Class II
- Labtician Buckling Sleeve™ — Labtician Ophthalmics, Inc · Class II
- Silicone Tire 10mm — Labtician Ophthalmics, Inc · Class II
- Silicone Tire 8.5mm — Labtician Ophthalmics, Inc · Class II
- Combo Pack — Labtician Ophthalmics, Inc · Class II
Cleared under the same submission
K875014 also covers:
- 3.0mm Round Sponge — Labtician Ophthalmics, Inc
- Accessory Sponge — Labtician Ophthalmics, Inc
- Accessory Sponge — Labtician Ophthalmics, Inc
- Boat — Labtician Ophthalmics, Inc
- Boat — Labtician Ophthalmics, Inc
- Circling Band — Labtician Ophthalmics, Inc
- Combo Pack — Labtician Ophthalmics, Inc
- Combo Pack — Labtician Ophthalmics, Inc
- Combo Pack — Labtician Ophthalmics, Inc
- Combo Pack — Labtician Ophthalmics, Inc
- Double Tantalum Clip 2.0mm — Labtician Ophthalmics, Inc
- Grooved Part Thickness Sponge — Labtician Ophthalmics, 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 |
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Manufacturer
- Manufacturer
- Labtician Ophthalmics, Inc
Sources (1)
- FDA UDI cd52a704-4fd2-4bf1-a3bb-2902ecd6c998 34 fields · synced Jun 8, 2026