FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigating Contact Lens
DI: 00853480006143
·
Model: Minus
·
ESCALON MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Irrigating Contact Lens
- Primary DI
- 00853480006143
- Version / Model
- Minus
- Catalog Number
- TR9841-11
- Company Name
- ESCALON MEDICAL CORP.
- Labeler DUNS
- 879144426
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9401d81a-8eb4-45bc-8d74-53a726eeed68
Device Description
For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single use requiring no clean up.
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
- No
- 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 |
|---|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | 886.4360 | 1 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00853480006143 | GS1 |
Customer Contacts
- Phone
- 800-486-4848
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K924999 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit