FDA UDI
In Commercial Distribution
🇺🇸 United States
Vitrectomy contact lens, single-use
DI: 03760087122183
·
Model: DISPOSABLE VITRECTOMY LENS
·
FCI S A S FCI 20 22
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Vitrectomy contact lens, single-use
- Primary DI
- 03760087122183
- Version / Model
- DISPOSABLE VITRECTOMY LENS
- Catalog Number
- S5.7010U
- Company Name
- FCI S A S FCI 20 22
- Labeler DUNS
- 763408366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-02-25
- Public Version
- 1
- Public Version Date
- 2020-03-04
- Public Version Status
- New
- Public Device Record Key
- e1850e9f-56ab-40a4-8a3c-dc78ca81e3c8
Device Description
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | Ophthalmic | 886.1385 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58070 | Vitrectomy contact lens, single-use | A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 53760087122188 | GS1 | ||||
| Primary | 03760087122183 | GS1 |
Customer Contacts
- Phone
- 800-932-4202
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 30 | degree |