ABDOMINAL AORTIC CLAMP - ABDOMINAL AORTIC CLAMP ATRAUMATIC JAW CURVED - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: ABDOMINAL AORTIC CLAMP ATRAUMATIC JAW CURVED SIDEWAYS

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More Product Details

Catalog Number

441-714

Brand Name

ABDOMINAL AORTIC CLAMP

Version/Model Number

441-714

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2020

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

K092544

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

4391feb6-75b6-4380-a113-0fa12c84880f

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414