Nordson Medical - Applicator Assembly procedure kit with spray tips - MICROMEDICS, INC.

Duns Number:066839630

Device Description: Applicator Assembly procedure kit with spray tips

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More Product Details

Catalog Number

-

Brand Name

Nordson Medical

Version/Model Number

620-00-02

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

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

83d3e3c1-6d43-43a6-b2f1-e6f7a0044d01

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Additional Identifiers

Package DI Number

10815634020914

Quantity per Package

1

Contains DI Package

00815634020917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack

"MICROMEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 34