MICROAIRE® - SHOWER SPRAY TIP WITH SPLASH SHIELD - Apex (Guangzhou) Tools & Orthopedics Co.

Duns Number:529936792

Device Description: SHOWER SPRAY TIP WITH SPLASH SHIELD

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More Product Details

Catalog Number

201-00-37

Brand Name

MICROAIRE®

Version/Model Number

201-00-37

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)

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

FQH

Product Code Name

Lavage, Jet

Device Record Status

Public Device Record Key

cb3d9019-6bcd-4a93-bcb0-d64c28f19daa

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

November 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"APEX (GUANGZHOU) TOOLS & ORTHOPEDICS CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 14