Identity
- Trade Name
- Combo Pack FDA UDI
- Generic Name
- Scleral buckling device, bioabsorbable FDA UDI
- Device Name
- Combo Pack FDA UDI
- Model / Reference
- S 6983 FDA UDI
- Description
- Combo Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10871321002304 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
Combo Pack 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
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- Silicone Tire 10mm — Labtician Ophthalmics, Inc · Class II
- Silicone Tire 8.5mm — Labtician Ophthalmics, Inc · Class II
- Oblong Sponge — 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
- Double Tantalum Clip 2.0mm — Labtician Ophthalmics, Inc
- Grooved Part Thickness Sponge — Labtician Ophthalmics, Inc
- Grooved 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 e69ad1b8-abe4-4071-8886-ae1e8a732f0c 35 fields · synced May 31, 2026