DEBAKEY FORCEPS - DEBAKEY FORCEPS JAW ROUND SPRING HANDLE WITHOUT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: DEBAKEY FORCEPS JAW ROUND SPRING HANDLE WITHOUT RATCHET

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More Product Details

Catalog Number

-

Brand Name

DEBAKEY FORCEPS

Version/Model Number

2100-827

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 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

-

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

HTD

Product Code Name

Forceps

Device Record Status

Public Device Record Key

5789a956-ecce-48f9-8683-1ebb9e7cfac0

Public Version Date

August 21, 2019

Public Version Number

8

DI Record Publish Date

August 08, 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