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Sonata® IUUS probe Leak Tester Kit

FDA UDI

Class I (US FDA UDI)

by Gynesonics, Inc.

Identity

Trade Name
Sonata® IUUS probe Leak Tester Kit FDA UDI
Generic Name
Invasive medical device leak tester, mechanical FDA UDI
Device Name
Invasive medical device leak tester, mechanical. FDA UDI
Model / Reference
ACCY-016 FDA UDI
Description
Invasive medical device leak tester, mechanical. FDA UDI

Identifiers

Catalog Number
ACCY-016 FDA UDI
Primary DI / UDI-DI
10817929020449 FDA UDI
FDA Product Code
FCY FDA UDI
GMDN Term
Invasive medical device leak tester, mechanical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Invasive medical device leak tester, mechanical

Sonata® IUUS probe Leak Tester Kit by Gynesonics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive medical device leak tester, mechanical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gynesonics, Inc.

Sources (1)

  • FDA UDI 7c6469ef-12e7-46ee-8bdd-c0128f544c51 35 fields · synced May 30, 2026