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Tula

FDA UDI

Class III (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
TULA FDA UDI
Generic Name
Drug-delivery iontophoresis system, single-use FDA UDI
Device Name
TULA KIT- UNILATERAL (NST007068) FDA UDI
Model / Reference
72290089 FDA UDI
Description
TULA KIT- UNILATERAL (NST007068) FDA UDI

Identifiers

Catalog Number
72290089 FDA UDI
Primary DI / UDI-DI
00885556817667 FDA UDI
PMA Number
P190016 FDA UDI
FDA Product Code
QJA FDA UDI
GMDN Term
Drug-delivery iontophoresis system, single-use FDA UDI

Classification

Device Class
Class III 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

Yes

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

Category: Tympanostomy tubeDrug-delivery iontophoresis system, single-use

Tula by Smith & Nephew, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drug-delivery iontophoresis system, single-use.

Cleared under the same submission

P190016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 3d586ed6-48e2-4aa6-bda7-7134d7381fc2 36 fields · synced Jun 8, 2026