Identity
- Trade Name
- ADAPTOR FOR F SIZE CO2 CYLINDER FDA UDI
- Generic Name
- Ophthalmic cryosurgical system, electronic FDA UDI
- Model / Reference
- 2508-P-7016 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272707503 FDA UDI
- FDA Product Code
- HRN FDA UDI
- GMDN Term
- Ophthalmic cryosurgical system, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4170 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic cryosurgical system, electronic
Adaptor For F Size Co2 Cylinder by Keeler Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic cryosurgical system, electronic.
- Cryo Probe: Extended Retinal, 2.5mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Frigitronics — CooperSurgical, Inc. · Class II
- Cryomatic 2.5mm Std Ret Pencil — KEELER LIMITED · Class II
- 3mm Glaucoma Pencil — KEELER LIMITED · Class II
- ADAPTOR FOR F SIZE N2O CYLINDER — KEELER LIMITED · Class II
- 2.5mm Extended Retinal Pencil — KEELER LIMITED · Class II
- 2.5mm Mid-Reach Retinal Pencil — KEELER LIMITED · Class II
- 1.5mm Curved Cataract Pencil — KEELER LIMITED · Class II
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
- Keeler Limited
Sources (1)
- FDA UDI c04a76a7-8e39-4b22-a3b6-17d76f57e16f 32 fields · synced May 30, 2026