Hood, Small Bubblegum, 24 Pack - ACCUTRON, INC.

Duns Number:088302096

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More Product Details

Catalog Number

33017-12

Brand Name

Hood, Small Bubblegum, 24 Pack

Version/Model Number

33017-12

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"

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 Details

Product Code

KHA

Product Code Name

Mask, Scavenging

Device Record Status

Public Device Record Key

f0d926d3-f97a-4501-aef5-49023d50f016

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

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