FDA UDI
In Commercial Distribution
🇺🇸 United States
Visian Toric ICL (Implantable Collamer Lens for Myopia)
DI: 00841542105286
·
Model: TMICL 12.1 (-14.0/3.5)
·
STAAR SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Visian Toric ICL (Implantable Collamer Lens for Myopia)
- Primary DI
- 00841542105286
- Version / Model
- TMICL 12.1 (-14.0/3.5)
- Catalog Number
- TMICL12.1
- Company Name
- STAAR SURGICAL COMPANY
- Labeler DUNS
- 054751110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-17
- Public Version
- 1
- Public Version Date
- 2018-11-19
- Public Version Status
- New
- Public Device Record Key
- 73837630-a500-47d8-b4c9-e4113a3622ba
Device Description
Diopter: -14.0; Cylinder 3.5; Overall Diameter (Length): 12.1
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
- No
- 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 |
|---|---|---|---|---|
| QCB | Phakic Toric Intraocular Lens | Ophthalmic | 886.3600 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47402 | Umbilical cord clamp/cutter | A sterile, hand-held manual surgical instrument designed with a clamping and cutting mechanism to simultaneously clamp and sever the umbilical cord immediately after birth. It may be used on the maternal side of the umbilical cord and on the infant side, typically where the clamp remains until the cord stub falls off. It is typically made of plastic materials [e.g., polycarbonate (PC)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841542105286 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030016 | 001 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius