Catalog Number

022012

Brand Name

C1® DEPTH LIMITER

Version/Model Number

022012

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

-

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

K100593

Product Code

HCF

Product Code Name

INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Public Device Record Key

19027be8-4fba-4870-bd0c-03fda9e3abac

Public Version Date

March 30, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-