AccessGUDID - DEVICE: Multifunctional Tool (06938695540300)

GUDID

Device Identifier (DI) Information

Brand Name: Multifunctional Tool
Version or Model: FG5400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG5400
Company Name: Shanghai Kinetic Medical Co., Ltd.

Primary DI Number: 06938695540300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 528198569 *Terms of Use

Device Description: Multifuctional Tool, Pyramid Tip, 22/23mm

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:	Yes
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?
58031	Bone access channel kit	A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope
NDN	Cement, Bone, Vertebroplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113742	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 22 Millimeter
Length: 23 Millimeter

Device Record Status

Public Device Record Key: 82997709-d2f6-4fc0-9b1e-514f98a10a3e
Public Version Date: June 08, 2020
Public Version Number: 1
DI Record Publish Date: May 31, 2020