SCANLAN® Aorta Vein Punch - Aorta Vein Punch - SCANLAN INTERNATIONAL INC

Duns Number:023055619

Device Description: Aorta Vein Punch

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More Product Details

Catalog Number

1001-06A

Brand Name

SCANLAN® Aorta Vein Punch

Version/Model Number

1001-06A

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

-

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

51201085-777c-40ec-adc2-3f24434a7b36

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCANLAN INTERNATIONAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1949
2 A medical device with a moderate to high risk that requires special controls. 855