Neonatal Manual Percussor Cup - Neonatal Manual Percussor Cup; 34mm - Medicomp

Duns Number:154454730

Device Description: Neonatal Manual Percussor Cup; 34mm

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More Product Details

Catalog Number

MC-2234

Brand Name

Neonatal Manual Percussor Cup

Version/Model Number

MC-2234

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GWZ

Product Code Name

Percussor

Device Record Status

Public Device Record Key

c7cf7785-9737-413f-aa70-87353edba31b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 11, 2017

Additional Identifiers

Package DI Number

10858409005303

Quantity per Package

50

Contains DI Package

00858409005306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDICOMP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 53
2 A medical device with a moderate to high risk that requires special controls. 5