GoodSense - Tan Large Nasal Strips - GEISS, DESTIN & DUNN, INC

Duns Number:076059836

Device Description: Tan Large Nasal Strips

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More Product Details

Catalog Number

-

Brand Name

GoodSense

Version/Model Number

846036004212

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)

-

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

LWF

Product Code Name

Dilator, Nasal

Device Record Status

Public Device Record Key

ee5c9b04-cf0a-447c-a324-e3cc61046bf1

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Additional Identifiers

Package DI Number

10846036004219

Quantity per Package

36

Contains DI Package

00846036004212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"GEISS, DESTIN & DUNN, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 14