Catalog Number

-

Brand Name

neoClose 2 Anchor (Long Driver) US

Version/Model Number

NCAALX2-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

K142903,K142903,K142903

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

8fceaa71-09e4-4f8f-8d76-5608f4753289

Public Version Date

August 03, 2018

Public Version Number

1

DI Record Publish Date

July 03, 2018

Package DI Number

05391529640569

Quantity per Package

8

Contains DI Package

05391529640552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper