Catalog Number

-

Brand Name

Barraquer Needle Holder

Version/Model Number

12-52299

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HNM

Product Code Name

Needle, Ophthalmic Suturing

Public Device Record Key

56371768-51d4-490b-84c8-ed26ae297198

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-