FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroStaar
DI: 20840311300017
·
Model: MSI-TF
·
STAAR SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- MicroStaar
- Primary DI
- 20840311300017
- Version / Model
- MSI-TF
- Catalog Number
- MSI-TF
- Company Name
- STAAR SURGICAL COMPANY
- Labeler DUNS
- 054751110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-06-15
- Public Version
- 1
- Public Version Date
- 2023-06-23
- Public Version Status
- New
- Public Device Record Key
- c3254f52-100c-4662-99bd-58ce43bfccf3
Device Description
Reusable Injector
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47724 | Manual intraocular lens injector, reusable | A hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of lightweight metal materials [e.g., titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00840311300013 | GS1 | ||||
| Primary | 20840311300017 | GS1 | ||||
| Direct Marking | 00840311300013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980696 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius