Hood Assortment, ClearView Scavenger - ACCUTRON, INC.

Duns Number:088302096

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More Product Details

Catalog Number

27663

Brand Name

Hood Assortment, ClearView Scavenger

Version/Model Number

27663

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 14, 2199

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)

Yes

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

KHA

Product Code Name

Mask, Scavenging

Device Record Status

Public Device Record Key

3b02b5d8-19c7-4a2c-8773-132b85c557ff

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCUTRON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 344
2 A medical device with a moderate to high risk that requires special controls. 192