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Shepard Activent®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
Shepard Activent® FDA UDI
Generic Name
Tympanostomy tube FDA UDI
Device Name
VENT TUBE 1046025 10PK PAIR SHEP W/TAIL FDA UDI
Model / Reference
1046025 FDA UDI
Description
VENT TUBE 1046025 10PK PAIR SHEP W/TAIL FDA UDI

Identifiers

Primary DI / UDI-DI
00681490031370 FDA UDI
510(k) Number
K941407 FDA UDI
FDA Product Code
ETD FDA UDI
GMDN Term
Tympanostomy tube FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3880 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

Shepard Activent® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K941407 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI a1c413df-6378-45fc-b572-c21ed3e8fb44 37 fields · synced Jun 1, 2026