Catalog Number

NDL-112-01

Brand Name

Needle

Version/Model Number

NDL-112-01

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"

Yes

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

4f63af24-9b04-4b6b-b310-bd98b8675432

Public Version Date

May 31, 2019

Public Version Number

1

DI Record Publish Date

May 23, 2019

Package DI Number

20841268108800

Quantity per Package

100

Contains DI Package

10841268108803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box