Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 70-0712C

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

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

fe3b7268-b53b-4a14-8978-d2d4419bd908

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

February 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-