Catalog Number

PSX

Brand Name

Proximate

Version/Model Number

PSX

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

bcd9ca81-9250-4ce8-926c-1b913f2a0864

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

July 15, 2016

Package DI Number

40705036013038

Quantity per Package

240

Contains DI Package

10705036013037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE