FDA UDI
In Commercial Distribution
🇺🇸 United States
Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack
DI: 10850681007174
·
Model: NA-DSP3PK
·
Novasignal Corp.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack
- Primary DI
- 10850681007174
- Version / Model
- NA-DSP3PK
- Catalog Number
- NA-DSP3PK
- Company Name
- Novasignal Corp.
- Labeler DUNS
- 078766464
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-05
- Public Version
- 3
- Public Version Date
- 2022-08-19
- Public Version Status
- Update
- Public Device Record Key
- 040d5be5-de4c-4f4d-baed-648d72d10058
Device Description
A box of 10 procedural sets that include replacement foam for the Temporal Monitoring Headframe.
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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63568 | Noninvasive vascular ultrasound support kit | A collection of non-sterile, non-powered, noninvasive devices intended to support a noninvasive vascular ultrasound system during location and assessment of vascular flow using ultrasound/Doppler/transit time technology. It consists of non-electronic supportive devices such as patient pads/positioners, transducer covers, and skin marking stickers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850681007174 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160442 | 000 |