Catalog Number

-

Brand Name

Silicone Block

Version/Model Number

Extra Large - Extra Long - Soft

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

K042380,K162624,K181387

Product Code

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

c9c0842c-4060-4e44-a95c-397ccb824850

Public Version Date

May 23, 2022

Public Version Number

2

DI Record Publish Date

February 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-