FDA UDI
In Commercial Distribution
🇺🇸 United States
SENSIMED Triggerfish® Recorder Sleeve
DI: 07640153470126
·
Model: 004
·
Sensimed SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SENSIMED Triggerfish® Recorder Sleeve
- Primary DI
- 07640153470126
- Version / Model
- 004
- Catalog Number
- ST4001
- 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
- 7
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 989db244-b7f6-46fe-9fc8-ae5ced203b56
Device Description
A box of ten SENSIMED Triggerfish® Recorder Sleeve
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
- No
- 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 |
|---|---|---|---|---|
| 31072 | Personal device holder, single-use | A portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640153470126 | GS1 |
Customer Contacts
- Phone
- +41216219191
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN140017 | 000 |