Catalog Number

-

Brand Name

neoClose AnchorGuard

Version/Model Number

NCAG-U

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

GDF

Product Code Name

Guide, Needle, Surgical

Public Device Record Key

921793bf-41b7-42c3-a6bb-31d0261c8b6b

Public Version Date

August 03, 2018

Public Version Number

1

DI Record Publish Date

July 03, 2018

Package DI Number

05391529640477

Quantity per Package

4

Contains DI Package

05391529640460

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper