TITANIUM CASTANEDA CLAMP - TITANIUM CASTANEDA CLAMP COOLEY JAWS STRAIGHT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: TITANIUM CASTANEDA CLAMP COOLEY JAWS STRAIGHT

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More Product Details

Catalog Number

-

Brand Name

TITANIUM CASTANEDA CLAMP

Version/Model Number

2605-200

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

K092544

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

d99cb3f4-0a11-4e7e-8cfe-a93fb1632862

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

August 21, 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