Catalog Number

15-1860Q

Brand Name

CASTROVIEJO NEEDLE HOLDER

Version/Model Number

15-1860Q

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

-

Product Code

HCF

Product Code Name

INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Public Device Record Key

2a407659-3da5-4fad-9674-26f079b29557

Public Version Date

March 12, 2021

Public Version Number

3

DI Record Publish Date

November 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-