SmartPractice - TruVol 20 microliter Precision Allergen - Smarthealth, Inc.

Duns Number:061081477

Device Description: TruVol 20 microliter Precision Allergen Dispenser, 20-pack

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More Product Details

Catalog Number

AL7950

Brand Name

SmartPractice

Version/Model Number

AL7950

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

JRC

Product Code Name

Micro Pipette

Device Record Status

Public Device Record Key

cde156ee-eb98-4ce4-852a-c9da74541b1c

Public Version Date

March 03, 2022

Public Version Number

2

DI Record Publish Date

December 04, 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