FDA UDI
In Commercial Distribution
🇺🇸 United States
Lenstar LS 900
DI: 07640132984200
·
Model: 1009000
·
Haag-Streit AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lenstar LS 900
- Primary DI
- 07640132984200
- Version / Model
- 1009000
- Catalog Number
- 1009000
- Company Name
- Haag-Streit AG
- Labeler DUNS
- 483467544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f4aa8490-f487-45c9-b758-3470a4d196b7
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Ophthalmic | 886.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48064 | Optical low coherence reflectometry (OLCR) biometer | A mains electricity (AC-powered) ophthalmic device (a biometer) designed to determine the axial dimensions and frontal section of the eye including other biometric parameters/evaluations such as keratometry, white-to-white distance, pupillometry and consequently corneal power based on optical low coherence reflectometry (OLCR), non contact, measurement methods using light markers and digital image processing. It is normally adjustable on a cross stage with an integral chin rest and used to obtain measurements directly from the eye for processing and display via software, e.g., in an attached computer. Patient intraocular lens (IOL) suitability may also be calculated using different formulae. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640132984200 | GS1 |
Customer Contacts
- Phone
- +41319780111
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 420 | Millimeter | |
| Depth | 260 | Millimeter | |
| Width | 310 | Millimeter |