FDA UDI
In Commercial Distribution
🇺🇸 United States
IOL Manipulator - Lester
DI: 00813465011135
·
Model: 6801
·
HURRICANE MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- IOL Manipulator - Lester
- Primary DI
- 00813465011135
- Version / Model
- 6801
- Catalog Number
- 6801
- Company Name
- HURRICANE MEDICAL INC
- Labeler DUNS
- 093377724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-05-08
- Public Version
- 1
- Public Version Date
- 2020-05-18
- Public Version Status
- New
- Public Device Record Key
- 82deb134-c507-4b6c-9ccc-6808e6ee1246
Device Description
Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm.
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
- Yes
- PM Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Radiation Sterilization", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYB | Lens, Guide, Intraocular | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11290 | Open-surgery dissector | A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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 | 10813465011132 | GS1 | ||||
| Primary | 00813465011135 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 22 | Millimeter | |
| Outer Diameter | 0.25 | Millimeter |