DuploSpray - DuploSpray MIS Applicator with Snap Lock, 20cm - MICROMEDICS, INC.

Duns Number:066839630

Device Description: DuploSpray MIS Applicator with Snap Lock, 20cm

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More Product Details

Catalog Number

-

Brand Name

DuploSpray

Version/Model Number

0601133

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

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

K061092,K061092,K061092

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

67876642-9934-439b-815a-b66da6162377

Public Version Date

April 09, 2021

Public Version Number

2

DI Record Publish Date

June 15, 2018

Additional Identifiers

Package DI Number

20815634020577

Quantity per Package

1

Contains DI Package

10815634020570

Package Discontinue Date

January 01, 2025

Package Status

In Commercial Distribution

Package Type

Ship Box

"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