FDA UDI
In Commercial Distribution
🇺🇸 United States
Treatment Pack (Size L)
DI: 04049471110159
·
Model: 1015
·
Carl Zeiss Meditec AG
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Treatment Pack (Size L)
- Primary DI
- 04049471110159
- Version / Model
- 1015
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 314594680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-02-09
- Public Version
- 1
- Public Version Date
- 2024-02-19
- Public Version Status
- New
- Public Device Record Key
- 000fcf52-27c0-4471-bfd5-e848ee056023
Device Description
single use accessory for ZEISS femtosecond lasers
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 |
| HNO | Keratome, Ac-Powered | Ophthalmic | 886.4370 | 1 |
| OTL | Femtosecond Laser System For Refractive Correction | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57995 | Femtosecond ophthalmic solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions (cataract incisions, arcuate corneal/scleral cuts/tunnels, anterior capsulotomy, phacofragmentations, corneal flaps, lamellar/perforating keratoplasty). The system includes a beam delivery device, imaging device, computer, software and controls; it cuts by micro-photodisruption of tissue created by focused ultra-short [femtosecond (FS)] pulses; it does not include fundus imaging technology and the therapeutic laser is not frequency-doubled. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04049471100150 | GS1 | ||||
| Primary | 04049471110159 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150040 | 012 |