Satin™ - Satin Macintosh Blade-FO,#3 - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: Satin Macintosh Blade-FO,#3

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More Product Details

Catalog Number

4073F

Brand Name

Satin™

Version/Model Number

4073F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Device Record Status

Public Device Record Key

ee9ee533-e5a2-474a-ad9a-c605d30bca5e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

00634782502188

Quantity per Package

8

Contains DI Package

00634782802189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"AMERICAN DIAGNOSTIC CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2395
2 A medical device with a moderate to high risk that requires special controls. 1769