Sticky Whiskers - Sticky-Whiskers Securement Device for infants - SALTER LABS

Duns Number:022721133

Device Description: Sticky-Whiskers Securement Device for infants

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More Product Details

Catalog Number

SW102-0-25

Brand Name

Sticky Whiskers

Version/Model Number

SW102-0-25

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

CBH

Product Code Name

DEVICE, FIXATION, TRACHEAL TUBE

Device Record Status

Public Device Record Key

59505721-3050-4c04-8ca4-7658abe6cc52

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134