AccessGUDID - DEVICE: DISPOSABLE SUPER CUT FINE NEEDLE (00192896009417)

GUDID

Device Identifier (DI) Information

Brand Name: DISPOSABLE SUPER CUT FINE NEEDLE
Version or Model: ES61HS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES61HS
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896009417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: DISPOSABLE SUPER CUT TUNGSTEN CARBIDE MODIFIED FINE NEEDLE WITH HEAT SHRINK SET

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?
61876	Open-surgery electrosurgical electrode, monopolar, reusable	An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGI	Electrocautery, Gynecologic (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942986	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 4.5 Millimeter

Device Record Status

Public Device Record Key: 9c4aef3c-f5f7-4246-b5b0-69521d71afac
Public Version Date: September 17, 2018
Public Version Number: 1
DI Record Publish Date: August 16, 2018