Catalog Number

US067

Brand Name

AESCULAP

Version/Model Number

US067

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NNI

Product Code Name

CONTAINER, SPECIMEN, NON-STERILE

Public Device Record Key

912beb8f-3664-4857-874c-2fdf7be52811

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

August 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-