FDA UDI
In Commercial Distribution
🇺🇸 United States
MICOR extractor
DI: 00860000122368
·
Model: FG-50621
·
Carl Zeiss Meditec, Cataract Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- MICOR extractor
- Primary DI
- 00860000122368
- Version / Model
- FG-50621
- Company Name
- Carl Zeiss Meditec, Cataract Technology, Inc.
- Labeler DUNS
- 080125056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-01-29
- Public Version
- 2
- Public Version Date
- 2023-04-21
- Public Version Status
- Update
- Public Device Record Key
- 950eb7cd-38a1-47d1-8341-09b3335aa9ca
Device Description
Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631.
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
- Yes
- 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 |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45071 | Phacoemulsification system | An assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric) through a dedicated handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefaction and removal of the opaque lens nucleus in cataract surgery). The system will typically consist of a mains electricity (AC-powered) generator providing the energy, an irrigation and suction system for the removal of the debris, handpieces and cables, the tips/needles/electrodes, and a foot control. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10860000122365 | GS1 | ||||
| Primary | 00860000122368 | GS1 | ||||
| Package | 30860000122369 | GS1 | Corrugated Cardboard | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 925-595-9817
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200584 | 000 |