DEVICE: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24 (00858736006045)
Device Identifier (DI) Information
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24
7013-5715
In Commercial Distribution
7013-5715
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
7013-5715
In Commercial Distribution
7013-5715
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36136 | Haemostatic knife |
A hand-operated surgical instrument, similar in appearance to a surgical scalpel, designed for simultaneous cutting of tissues and cauterization (haemostasis) of blood vessels by applying an electrically-heated blade. It typically consists of a high-resistance, flat, sharp blade at the distal end and a handle at the proximal end with an electric cable; the blade is typically an integral part of the knife. Haemostasis is induced by direct transmission of thermal energy (heat) from the blade to the tissues; negating the use of grounding electrodes. It is used for a variety of procedures, including general and plastic surgery, gynaecology, and orthopaedics. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K033089 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7313211d-63b3-4c69-b9a7-1f04f9a3261d
July 06, 2018
3
August 02, 2016
July 06, 2018
3
August 02, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00858736006137
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(901)261-0012
customerservice@hemostatix.com
customerservice@hemostatix.com