NANA - LONG ASH TUNNELERLONG ASH TUNNEL - Medical Components, Inc.

Duns Number:038000253

Device Description: LONG ASH TUNNELERLONG ASH TUNNEL

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More Product Details

Catalog Number

DAST-L

Brand Name

NANA

Version/Model Number

DAST-L

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)

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

DRC

Product Code Name

Trocar

Device Record Status

Public Device Record Key

8701090c-9538-4a2d-848f-00c1b01c9ebc

Public Version Date

August 19, 2019

Public Version Number

1

DI Record Publish Date

August 10, 2019

Additional Identifiers

Package DI Number

50884908145699

Quantity per Package

5

Contains DI Package

00884908145694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560