AccessGUDID - DEVICE: Convertible Kerrison Rongeur (00192896116863)

GUDID

Device Identifier (DI) Information

Brand Name: Convertible Kerrison Rongeur
Version or Model: 404-340C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 404-340C
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896116863
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: Convertible Kerrison Rongeur With Ejector Pin 10 Millimeter Opening Angled Up 40 Degrees

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":	Yes
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?
32853	Orthopaedic joint/limb rongeur	A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTX	RONGEUR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Shaft Length: 8 Inch
Device Size Text, specify: Bite Width 4 Millimeter

Device Record Status

Public Device Record Key: 2b7d33f3-ba01-4e9b-b4e5-90146351da2d
Public Version Date: March 18, 2024
Public Version Number: 1
DI Record Publish Date: March 08, 2024