Catalog Number

102-0102

Brand Name

I-SIL Bite Registration SP

Version/Model Number

102-0102

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

4c385b8f-bda7-4915-85a6-80d72b6fde4d

Public Version Date

September 21, 2022

Public Version Number

7

DI Record Publish Date

February 20, 2017

Package DI Number

02020070318117

Quantity per Package

25

Contains DI Package

08809262959871

Package Discontinue Date

December 31, 2019

Package Status

Not in Commercial Distribution

Package Type

-