Temena

FDA UDI

Class II (US FDA UDI)

by Te ME NA Sas

Identity

Trade Name: Temena FDA UDI
Generic Name: Peripheral nerve-block sharp needle FDA UDI
Device Name: Stimulation Needle 30º bevel 22G x 70 mm FDA UDI
Model / Reference: 83070-22 FDA UDI
Description: Stimulation Needle 30º bevel 22G x 70 mm FDA UDI

Identifiers

Catalog Number: 83070-22 FDA UDI
Primary DI / UDI-DI: 03700339713356 FDA UDI
FDA Product Code: GXZ FDA UDI
GMDN Term: Peripheral nerve-block sharp needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 70 Millimeter FDA UDI
Needle Gauge — 22 Gauge FDA UDI
Angle — 30 degree FDA UDI

Category: Peripheral nerve-block sharp needle

Temena by Te ME NA Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Spinal Needle — HAKKO CO., LTD. · Class II
OWL — Diros Technology, Inc. · Class II
SONOBLOCK — Pajunk GmbH Medizintechnologie · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Te ME NA Sas

Sources (1)

FDA UDI feb7cf47-0f73-4355-b219-4721f49bad7d 35 fields · synced May 30, 2026