FDA UDI
In Commercial Distribution
🇺🇸 United States
SUPER VIEW Lens, Disposable Contact, Tornambe
DI: 00856222004209
·
Model: 40413
·
OCULUS SURGICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SUPER VIEW Lens, Disposable Contact, Tornambe
- Primary DI
- 00856222004209
- Version / Model
- 40413
- Catalog Number
- 40413
- Company Name
- OCULUS SURGICAL INC
- Labeler DUNS
- 015409582
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-13
- Public Version
- 1
- Public Version Date
- 2024-08-21
- Public Version Status
- New
- Public Device Record Key
- 88308905-2722-441a-81b2-4e7fa4f71d1b
Device Description
SUPER VIEW Tornambe Disposable Contact Lens for use visualizing the fundus during vitreo-retinal surgery.
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10856222004206 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00856222004209 | GS1 |
Customer Contacts
- Phone
- 772-236-2622
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051630 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 13 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius