FDA UDI
In Commercial Distribution
🇺🇸 United States
UNIPURE & UNIPEXY
DI: 00380657530694
·
Model: 8065753069
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- UNIPURE & UNIPEXY
- Primary DI
- 00380657530694
- Version / Model
- 8065753069
- Catalog Number
- 8065753069
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-28
- Public Version
- 1
- Public Version Date
- 2024-11-05
- Public Version Status
- New
- Public Device Record Key
- ee2ecb7c-b20e-4485-adb2-a18b58bcc10f
Device Description
UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | Ophthalmic | 886.4270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45209 | Sulfur hexafluoride refillable cylinder | A container designed as a refillable cylinder used to hold compressed medical grade sulphur hexafluoride (SF6) under safe conditions at high pressure. It is typically filled with SF6 when delivered from the gas/device supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote SF6 content. The cylinder is typically made of steel and must be used together with a pressure regulator in order to release the SF6 at the correct working pressure. SF6 is used predominately as a tamponade gas to aid the healing process from retinal surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10380657530691 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00380657530694 | GS1 |