FDA UDI
In Commercial Distribution
🇺🇸 United States
Irrigating Contact Lens
DI: 00853480006136
·
Model: Flat
·
ESCALON MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Irrigating Contact Lens
- Primary DI
- 00853480006136
- Version / Model
- Flat
- Catalog Number
- TR9840-11
- 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
- 8baf9317-8a69-44a5-9a9e-b93601129528
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 | 00853480006136 | 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
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius