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TetraSens

FDA UDI

Class II (US FDA UDI)

by Senzime AB (Publ.)

Identity

Trade Name
TetraSens FDA UDI
Generic Name
Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Device Name
TetraSens with EZconnect FDA UDI
Model / Reference
SEN 2012 TetraSens FDA UDI
Description
TetraSens with EZconnect FDA UDI

Identifiers

Catalog Number
SEN 2012 FDA UDI
Primary DI / UDI-DI
07350012440169 FDA UDI
FDA Product Code
KOI FDA UDI
GMDN Term
Block-monitoring peripheral nerve electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2775 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Block-monitoring peripheral nerve electrical stimulation system

TetraSens by Senzime AB (Publ.) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Block-monitoring peripheral nerve electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Senzime AB (Publ.)

Sources (1)

  • FDA UDI b227d4ac-2b8f-4371-b2c1-019c85480034 35 fields · synced May 31, 2026