FDA UDI
In Commercial Distribution
🇺🇸 United States
SENSIMED Triggerfish® Sensor FLAT
DI: 07640153470065
·
Model: F.V.4
·
Sensimed SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SENSIMED Triggerfish® Sensor FLAT
- Primary DI
- 07640153470065
- Version / Model
- F.V.4
- Catalog Number
- BO3F
- Company Name
- Sensimed SA
- Labeler DUNS
- 482491177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 24331f7f-0aa8-4a34-9511-83c514d82f0b
Device Description
A box of three FLAT SENSIMED Triggerfish® Sensors
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PLZ | Ocular Pattern Recorder | Ophthalmic | 886.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62111 | Ocular volume ambulatory recording system sensor | A sterile, electronic component of an ambulatory ocular volume recording system which is in the form of a contact lens containing a sensor designed to measure and transmit variations in ocular volume (i.e., circumferential changes at the corneoscleral area), to indicate patterns of intraocular pressure (IOP) fluctuation. It is worn during daily activities and sleep (e.g., by patients at risk of glaucoma progression). It is powered by and wirelessly communicates with a patient-worn transceiver which is connected to a recorder. Recorded data is displayed and analysed by an off-the-shelf computing device (e.g., laptop) using dedicated software. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640153470065 | GS1 |
Customer Contacts
- Phone
- +41216219191
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN140017 | 000 |