Catalog Number

119 700

Brand Name

ACHILLON®

Version/Model Number

119700ND

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"

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

HCF

Product Code Name

INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Public Device Record Key

39a8f091-a409-4f43-91b5-a9a2d9f233f5

Public Version Date

November 16, 2018

Public Version Number

1

DI Record Publish Date

October 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-