Mammosite Variable 4-5 cm Applicator Tray - Hologic, Inc.

Duns Number:018925968

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More Product Details

Catalog Number

919007-01

Brand Name

Mammosite Variable 4-5 cm Applicator Tray

Version/Model Number

919007-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K011690,K011690

Product Code Details

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

dc84627d-969c-4762-a5d7-a4872ddc3c36

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2016

Additional Identifiers

Package DI Number

25420045505008

Quantity per Package

1

Contains DI Package

15420045505001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"HOLOGIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 130
2 A medical device with a moderate to high risk that requires special controls. 311
3 A medical device with high risk that requires premarket approval 96