FDA UDI
In Commercial Distribution
🇺🇸 United States
Thumb adapter TOF3D
DI: EMIP57501015
·
Model: 5750101
·
MIPM Mammendorfer Institut für Physik und Medizin GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Thumb adapter TOF3D
- Primary DI
- EMIP57501015
- Version / Model
- 5750101
- Catalog Number
- 5750101
- Company Name
- MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Labeler DUNS
- 324416379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-05-30
- Public Version
- 1
- Public Version Date
- 2022-06-07
- Public Version Status
- New
- Public Device Record Key
- 201b2ab8-7a7d-4aca-ac5c-6a1420c17e02
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| KOI | Stimulator, Nerve, Peripheral, Electric | Anesthesiology | 868.2775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62743 | Sensor holder, single-use | A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | EMIP57501010 | HIBCC | ||||
| Primary | EMIP57501015 | HIBCC |
Customer Contacts
- Phone
- +49814592090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212434 | 000 |