Clear Passage Nasal Strips - Nasal Strips, Clear Medium - Aso LLC

Duns Number:152793493

Device Description: Nasal Strips, Clear Medium

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More Product Details

Catalog Number

-

Brand Name

Clear Passage Nasal Strips

Version/Model Number

017276238631

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

e616e971-b1b3-4391-9f13-2b2862cac2b2

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Additional Identifiers

Package DI Number

20017276238635

Quantity per Package

48

Contains DI Package

00017276238631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"ASO LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48
2 A medical device with a moderate to high risk that requires special controls. 4
U Unclassified 1