FDA UDI
In Commercial Distribution
🇺🇸 United States
Contact Lens, HD Professional, Cohen-Benner, "CBC"
DI: 00852475007202
·
Model: 54013
·
OCULUS SURGICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Contact Lens, HD Professional, Cohen-Benner, "CBC"
- Primary DI
- 00852475007202
- Version / Model
- 54013
- Catalog Number
- 54013
- Company Name
- OCULUS SURGICAL INC
- Labeler DUNS
- 015409582
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-26
- Public Version
- 3
- Public Version Date
- 2021-06-02
- Public Version Status
- Update
- Public Device Record Key
- 258d8ed9-0a8e-40db-9d03-0a0aa0e89799
Device Description
1 Each 54013 Contact Lens, HD Professional, Cohen-Benner Contact "CBC"
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
- 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 | 10852475007209 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00852475007202 | GS1 |
Customer Contacts
- Phone
- 7722362622
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051630 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 13.6 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius