AccessGUDID - DEVICE: AXIAL RING HANDLE (00192896007352)

GUDID

Device Identifier (DI) Information

Brand Name: AXIAL RING HANDLE
Version or Model: 2901-074
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2901-074
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896007352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use
Previous DI: B09929010740

Device Description: AXIAL RING HANDLE WITHOUT RATCHET

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?
63868	Laparoscopic surgery handle	A hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synthetic material with a straight handle grip. 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 [?]
K102921	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
Device Size Text, specify: FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS

Device Record Status

Public Device Record Key: 436cddde-0629-4171-ad65-7b3f75e47d8e
Public Version Date: May 07, 2025
Public Version Number: 2
DI Record Publish Date: August 22, 2018