Catalog Number

0101709

Brand Name

Hader

Version/Model Number

0101709

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

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

EGG

Product Code Name

Attachment, Precision, All

Public Device Record Key

80ac8b09-3f31-4175-9db9-f8413b8ec364

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

September 22, 2022

Package DI Number

00842092175392

Quantity per Package

50

Contains DI Package

00842092175385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-