COOLEY LIGATURE CARRIER CLAMP - COOLEY LIGATURE CARRIER CLAMP SERRATED SMALL JAW - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: COOLEY LIGATURE CARRIER CLAMP SERRATED SMALL JAW CURVED

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More Product Details

Catalog Number

-

Brand Name

COOLEY LIGATURE CARRIER CLAMP

Version/Model Number

2100-212

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2018

Issuing Agency

In HIBCC

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

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

c4e007cc-18c7-4939-baa2-382f6f26522e

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

September 01, 2017

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