Nordson Medical - Spray Applicator Kit - MICROMEDICS, INC.

Duns Number:066839630

Device Description: Spray Applicator Kit

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More Product Details

Catalog Number

-

Brand Name

Nordson Medical

Version/Model Number

800-0250

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

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Device Record Status

Public Device Record Key

68110abb-c637-42e4-ac8c-dfebb17e0907

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 25, 2021

Additional Identifiers

Package DI Number

10815634021218

Quantity per Package

1

Contains DI Package

00815634021211

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