Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 34-02005F-S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAB

Product Code Name

NEEDLE, SUTURING, DISPOSABLE

Public Device Record Key

db1b6acb-386f-486a-9d8f-ff7a0c44b501

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-