Catalog Number

AN162010B

Brand Name

AllPoints Port Access System SafeStep

Version/Model Number

AN162010B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PTI

Product Code Name

Non-coring (Huber) needle

Public Device Record Key

73c47897-2821-48ce-8ba8-d07e94b94df7

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

10801741215169

Quantity per Package

10

Contains DI Package

00801741215162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA