AccessGUDID - DEVICE: Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter (08058964726773)

GUDID

Device Identifier (DI) Information

Brand Name: Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter
Version or Model: 900028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900028
Company Name: G21 SRL

Primary DI Number: 08058964726773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431529195 *Terms of Use

Device Description: Kyphoplasty Balloon Catheter

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?
47021	Inflatable bone tamp	A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. 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 [?]
K172214	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 Temperature: between 50 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c4b1396-497c-410b-ab7c-597d5d5bdff0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 13, 2017