Catalog Number

793.99

Brand Name

Silvercrest

Version/Model Number

IAN 387870_2101

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

-

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

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

910d118b-6018-48e5-b31c-b3d76d40c4d0

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Package DI Number

14055334330081

Quantity per Package

4

Contains DI Package

04055334330084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case pack