SmartPractice - Universal Chamber Cover 50/box - Smarthealth, Inc.

Duns Number:061081477

Device Description: Universal Chamber Cover 50/box

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More Product Details

Catalog Number

AL910

Brand Name

SmartPractice

Version/Model Number

AL910

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Record Status

Public Device Record Key

e0429f50-1915-4c56-af47-fd05da765011

Public Version Date

March 01, 2022

Public Version Number

3

DI Record Publish Date

December 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMARTHEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 8
U Unclassified 18