SCANLAN® DeBakey Clamp - SCANLAN® DeBakey Clamp Custom 10 1/2" - SCANLAN INTERNATIONAL INC

Duns Number:023055619

Device Description: SCANLAN® DeBakey Clamp Custom 10 1/2"

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More Product Details

Catalog Number

2002-51-01

Brand Name

SCANLAN® DeBakey Clamp

Version/Model Number

2002-51-01

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

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

4fa889f4-a50a-47c5-9070-c95a4a9b06b0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 17, 2017

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