Catalog Number

ALM 2110

Brand Name

ALM SET

Version/Model Number

ALM SET V TYPE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MIJ

Product Code Name

Needle, Tumor Localization

Public Device Record Key

8482cda1-c8b6-4e8c-ad86-3416ac82b77f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 18, 2019

Package DI Number

48033003340170

Quantity per Package

20

Contains DI Package

08033003340172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-