Catalog Number

AMS-9059CP

Brand Name

VYGON

Version/Model Number

AMS-9059CP

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

OGJ

Product Code Name

Nerve block tray

Public Device Record Key

3bddca63-d904-413a-9a5f-409b14d8fb9b

Public Version Date

September 23, 2019

Public Version Number

1

DI Record Publish Date

September 13, 2019

Package DI Number

38498840013077

Quantity per Package

20

Contains DI Package

08498840013076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-