Catalog Number

-

Brand Name

Portex

Version/Model Number

24-2012-64

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K172800,K172800,K172800

Product Code

MIA

Product Code Name

NEEDLE, SPINAL, SHORT TERM

Public Device Record Key

0fa9563b-23b2-411d-91ed-dfc43c64a387

Public Version Date

March 17, 2020

Public Version Number

1

DI Record Publish Date

March 09, 2020

Package DI Number

55019517070734

Quantity per Package

10

Contains DI Package

35019517070730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet