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Canoe Vent Tube

FDA UDI

Class II (US FDA UDI)

by Grace Medical, Inc.

Identity

Trade Name
CANOE VENT TUBE FDA UDI
Generic Name
Tympanostomy tube FDA UDI
Device Name
CANOE VENT TUBE .76MM X 1.14MM ID SILICONE 5 PACK FDA UDI
Model / Reference
510-461 FDA UDI
Description
CANOE VENT TUBE .76MM X 1.14MM ID SILICONE 5 PACK FDA UDI

Identifiers

Primary DI / UDI-DI
00844505007771 FDA UDI
510(k) Number
K981575 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Canoe Vent Tube by Grace Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K981575 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Grace Medical, Inc.

Sources (1)

  • FDA UDI d6a34fa0-cf3b-42f7-9477-185882b7978e 36 fields · synced May 30, 2026