DEVICE: DEBAKEY AORTIC ANEURYSM CLAMP (B09921006940)

Device Identifier (DI) Information

DEBAKEY AORTIC ANEURYSM CLAMP
2100-694
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09921006940
HIBCC

1
040729840 *Terms of Use
DEBAKEY AORTIC ANEURYSM CLAMP CURVED JAW REVERSE CURVED SHANK
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Soft-tissue surgical forceps, scissors-like, reusable A hand-held, manual, open surgical instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DXC Clamp, Vascular
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 12 Inch
CLOSE

Device Record Status

4da3d597-c4d6-4bf2-873c-6b22deaf7c9a
April 24, 2018
4
August 19, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
800-821-7496
info@sontecinstruments.com
CLOSE