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Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack

FDA UDI

Class II (US FDA UDI)

by Novasignal Corporation

Identity

Trade Name
Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack FDA UDI
Generic Name
Noninvasive vascular ultrasound support kit FDA UDI
Device Name
A box of 10 procedural sets that include replacement foam for the Temporal Monitoring Headframe. FDA UDI
Model / Reference
NA-DSP3PK FDA UDI
Description
A box of 10 procedural sets that include replacement foam for the Temporal Monitoring Headframe. FDA UDI

Identifiers

Catalog Number
NA-DSP3PK FDA UDI
Primary DI / UDI-DI
10850681007174 FDA UDI
510(k) Number
K160442 FDA UDI
FDA Product Code
ITX FDA UDI
IYN FDA UDI
GMDN Term
Noninvasive vascular ultrasound support kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.1550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Noninvasive vascular ultrasound support kit

Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack by Novasignal Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Noninvasive vascular ultrasound support kit.

Cleared under the same submission

K160442 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novasignal Corporation

Sources (1)

  • FDA UDI 040d5be5-de4c-4f4d-baed-648d72d10058 35 fields · synced Jun 8, 2026