Catalog Number

ILS 0914-12

Brand Name

ATEC Introducer

Version/Model Number

ILS 0914-12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K042290,K042290

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

cc582297-a209-41fe-8627-e0b4fea34e73

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 03, 2015

Package DI Number

15420045503199

Quantity per Package

5

Contains DI Package

05420045503192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX