Grafco - #1 MACINTOSH STANDARD BLADE - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: #1 MACINTOSH STANDARD BLADE

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More Product Details

Catalog Number

1196#1

Brand Name

Grafco

Version/Model Number

1196#1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

0d56b3f2-0937-4338-858e-558faa21a175

Public Version Date

June 11, 2021

Public Version Number

1

DI Record Publish Date

June 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202