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Balloon Applicator Kit

FDA UDI

Class II (US FDA UDI)

by Icad, Inc.

Identity

Trade Name
Balloon Applicator Kit FDA UDI
Generic Name
Intraoperative/postoperative therapeutic x-ray system balloon applicator kit FDA UDI
Device Name
Balloon Applicator, 4-5 cm Spherical FDA UDI
Model / Reference
720331 FDA UDI
Description
Balloon Applicator, 4-5 cm Spherical FDA UDI

Identifiers

Catalog Number
AB2061 FDA UDI
Primary DI / UDI-DI
00858012005328 FDA UDI
510(k) Number
K090914 FDA UDI
FDA Product Code
JAD FDA UDI
GMDN Term
Intraoperative/postoperative therapeutic x-ray system balloon applicator kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Category: Intraoperative/postoperative therapeutic x-ray system balloon applicator kit

Balloon Applicator Kit by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative/postoperative therapeutic x-ray system balloon applicator kit.

Cleared under the same submission

K090914 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icad, Inc.

Sources (1)

  • FDA UDI 9d76a2dd-0d46-499c-993a-a3f313047c06 35 fields · synced Jun 1, 2026