FDA UDI
In Commercial Distribution
🇺🇸 United States
SENTIO
DI: 10705034534787
·
Model: 286202300
·
Medos International Sàrl
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SENTIO
- Primary DI
- 10705034534787
- Version / Model
- 286202300
- Catalog Number
- 286202300
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-08
- Public Version
- 1
- Public Version Date
- 2018-11-08
- Public Version Status
- New
- Public Device Record Key
- 189c7164-b08e-40df-9b12-9400fa669f06
Device Description
SENTIO MMG TABLET WITH SENTIO MMG SW
Device Characteristics
- Single Use
- No
- 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
- 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
- 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 |
|---|---|---|---|---|
| ETN | STIMULATOR, NERVE | Ear, Nose, Throat | 874.1820 | 2 |
| PDQ | Neurosurgical nerve locator | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36081 | Nerve-function monitor | A mains electricity (AC-powered) bedside device designed to continuously assess the adequacy of the nerve function of a non-ambulatory patient who requires monitoring (e.g., as a result of trauma, anaesthesia, intervention, evaluation). It typically monitors evoked potential (EP), electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response. It typically consists of electrodes applied to the patient intended to acquire the neural electrical signal, and a computerized unit to process and display the information; stimulation systems for nerve block and evoked potential evaluation are separate requirements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705034534787 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173526 | 000 |