FDA UDI
In Commercial Distribution
🇺🇸 United States
bioli™ IOL Delivery System
DI: 10814899027072
·
Model: BIOLI-D
·
AST PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- bioli™ IOL Delivery System
- Primary DI
- 10814899027072
- Version / Model
- BIOLI-D
- Company Name
- AST PRODUCTS, INC.
- Labeler DUNS
- 611655440
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-12-07
- Public Version
- 2
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 7496abec-3337-4c6f-91a5-2a12806837bb
Device Description
The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
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 |
|---|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47725 | Manual intraocular lens injector, single-use | 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 plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00814899027075 | GS1 | ||||
| Primary | 10814899027072 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200057 | 000 |