Catalog Number

-

Brand Name

SINGLE USE SPLINTING TUBE

Version/Model Number

ST-SB1

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

K071254,K071254,K071254

Product Code

FDA

Product Code Name

Enteroscope and accessories

Public Device Record Key

debe688c-f200-42e2-9348-d1531dfce0fb

Public Version Date

December 15, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

14953170237208

Quantity per Package

1

Contains DI Package

04953170237201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-