Catalog Number

1197-48

Brand Name

CareGuard®

Version/Model Number

1197-48

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"

Yes

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

-

Product Code

MNK

Product Code Name

Endoscopic Bite Block

Public Device Record Key

ec1e63d4-d8b6-4016-b4b5-60f4ad5c51be

Public Version Date

April 10, 2019

Public Version Number

4

DI Record Publish Date

September 17, 2016

Package DI Number

M7831197481

Quantity per Package

100

Contains DI Package

M7831197480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case