AccessGUDID - DEVICE: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE (B09929010960)

GUDID

Device Identifier (DI) Information

Brand Name: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE
Version or Model: 2901-096
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09929010960
Issuing Agency: HIBCC
Commercial Distribution End Date: September 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH ROTATION MODULE AND HIGH FREQUENCY CONNECTION

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?
32043	Laparoscopic surgical procedure kit, non-medicated, reusable	A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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 [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS

Device Record Status

Public Device Record Key: 059e717a-7e00-45c9-8216-b26db3a37e16
Public Version Date: September 24, 2018
Public Version Number: 4
DI Record Publish Date: August 19, 2016