Catalog Number

1145

Brand Name

SANDEL

Version/Model Number

1145

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)

-

Over the Counter (OTC)

Yes

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

542a011c-b94b-401a-b6de-9392ad506bd2

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

March 28, 2022

Package DI Number

35414566810144

Quantity per Package

2

Contains DI Package

25414566810147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case