AccessGUDID - DEVICE: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER (00858736006014)

GUDID

Device Identifier (DI) Information

Brand Name: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER
Version or Model: 7013-8400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7013-8400
Company Name: HEMOSTATIX MEDICAL TECHNOLOGIES LLC

Primary DI Number: 00858736006014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791221265 *Terms of Use

Device Description: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091107	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec26f5ad-cd14-4ab2-9e18-a9112db6ba24
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 02, 2016