FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Patient Interface 125 Kit
DI: 04050555000990
·
Model: 1
·
Technolas Perfect Vision GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Patient Interface 125 Kit
- Primary DI
- 04050555000990
- Version / Model
- 1
- Catalog Number
- 90000115
- Company Name
- Technolas Perfect Vision GmbH
- Labeler DUNS
- 341325716
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2024-03-14
- Public Version Status
- Update
- Public Device Record Key
- 7dceb23c-ef0d-4454-916a-938d7d9734e4
- Distribution End Date
- 2023-12-31
Device Description
Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher). Kit consists of Patient Interface 125 and Suction Clip 125.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
| OOE | Ophthalmic Femtosecond Laser | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41707 | Laser beam delivery unit holder | A device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04050555000990 | GS1 |
Customer Contacts
- Phone
- +4989940040
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius