Catalog Number

-

Brand Name

Microvascular Needle Holder

Version/Model Number

2300-342Q

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

-

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

FHQ

Product Code Name

HOLDER, NEEDLE, GASTROENTEROLOGIC

Public Device Record Key

bd0490de-a373-4079-b34a-887a326c08d8

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-