Cervical Applicator Set, Bundle 2 - Cervical Applicator Bundle 2 - Icad, Inc.

Duns Number:108870254

Device Description: Cervical Applicator Bundle 2

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More Product Details

Catalog Number

CG1002

Brand Name

Cervical Applicator Set, Bundle 2

Version/Model Number

710855

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123442

Product Code Details

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Device Record Status

Public Device Record Key

ea5ff3c7-d17f-4d79-9bce-9f915c56c2fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ICAD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 87