AccessGUDID - DEVICE: DISPOSABLE HANDSWITCH SUCTION COAGULATOR (00192896009462)

GUDID

Device Identifier (DI) Information

Brand Name: DISPOSABLE HANDSWITCH SUCTION COAGULATOR
Version or Model: SCH10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCH10
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896009462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: DISPOSABLE HAND SWITCH SUCTION COAGULATOR WITH CABLE

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?
47864	Surgical power tool hand-switch	A handle-like device that is attached (clips or is slid onto the cylindrical barrel) to an electrically- or pneumatically-powered surgical power tool handpiece or motor of the micro types (a drill or a saw) so that the two devices interact to function as a switch used by the operating surgeon to hand activate (start and stop) the handpiece/motor. It is typically made of metal and/or synthetic materials and will typically include a sliding lock that, when brought into use by the surgeon, will lock the handle in the "On" position. 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 [?]
K033003	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Meter
Device Size Text, specify: 12 French Inner Diameter

Device Record Status

Public Device Record Key: ace0ac1a-ae60-4dcf-82a7-fef965a73c00
Public Version Date: September 17, 2018
Public Version Number: 1
DI Record Publish Date: August 16, 2018