Catalog Number

-

Brand Name

MED-L

Version/Model Number

XL13150-0S

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

K192099,K192099

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

85a64d7a-bc02-4e7e-a0d4-583c3c07fc07

Public Version Date

July 16, 2020

Public Version Number

1

DI Record Publish Date

July 08, 2020

Package DI Number

18052283955903

Quantity per Package

10

Contains DI Package

08052283955906

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-