Catalog Number

SBS14-K

Brand Name

Sabella Flex

Version/Model Number

1

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"

-

For Single-Use

-

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

K122888,K122888

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

f4169250-11e2-433b-8f92-25507f99d5a5

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Package DI Number

10628341930267

Quantity per Package

1

Contains DI Package

00628341930260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-