FDA UDI
In Commercial Distribution
🇺🇸 United States
SENSIMED Triggerfish® Antenna RIGHT
DI: 07640153470119
·
Model: AR.3
·
Sensimed SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SENSIMED Triggerfish® Antenna RIGHT
- Primary DI
- 07640153470119
- Version / Model
- AR.3
- Catalog Number
- BO3AR
- 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
- 20039e42-6a30-497d-9815-a67233c83ef0
Device Description
A box of three SENSIMED Triggerfish® eye patch antennae for use around the right eye
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 62112 | Ocular monitoring/recording system ambulatory antenna, single-use | An external component of an ocular monitoring/recording system intended to enable continuous, wireless extraction of data from an implantable or nonimplantable ocular sensor (e.g., used to detect intraocular pressure (IOP) fluctuation in patients at risk of glaucoma progression); it may also be intended to allow wireless power transfer from the parent device to the sensor. It is intended to be connected to the system monitor or reader and worn at close proximity to the eye (e.g., attached to an included eye patch) to achieve a constant link with the sensor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640153470119 | GS1 |
Customer Contacts
- Phone
- +41216219191
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN140017 | 000 |