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Vaginal Applicator Set with Base and Clamp

FDA UDI

Class II (US FDA UDI)

by Icad, Inc.

Identity

Trade Name
Vaginal Applicator Set with Base and Clamp FDA UDI
Generic Name
Intraoperative/postoperative therapeutic x-ray system vaginal applicator FDA UDI
Device Name
Vaginal Applicator Bundle 2 FDA UDI
Model / Reference
720216 FDA UDI
Description
Vaginal Applicator Bundle 2 FDA UDI

Identifiers

Catalog Number
AG3010 FDA UDI
Primary DI / UDI-DI
00858012005458 FDA UDI
510(k) Number
K072616 FDA UDI
FDA Product Code
JAD FDA UDI
GMDN Term
Intraoperative/postoperative therapeutic x-ray system vaginal applicator 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

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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Intraoperative/postoperative therapeutic x-ray system vaginal applicator

Vaginal Applicator Set with Base and Clamp 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 vaginal applicator.

Cleared under the same submission

K072616 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 476d0c40-97e9-4b38-a7f0-134b64d4b1be 35 fields · synced Jun 8, 2026