Catalog Number

23-700-07

Brand Name

AlliedSil™ Sheeting

Version/Model Number

Size: 50.8mm x 76.2mm x 0.178mm

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

K971480,K971480

Product Code

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

f37368a0-2d72-48ab-bf4e-c5ef4bfbcf96

Public Version Date

November 15, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

M72423700072

Quantity per Package

10

Contains DI Package

M72423700071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box