AccessGUDID - DEVICE: KYPHON Express II Inflatable Bone Tamp (00763000025656)

GUDID

Device Identifier (DI) Information

Brand Name: KYPHON Express II Inflatable Bone Tamp
Version or Model: KE152
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00763000025656
Issuing Agency: GS1
Commercial Distribution End Date: January 29, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: BONE TAMP KE152 15/2 EXPRESS II IBT

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):	No
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
HXG	TAMP
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123771	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
Special Storage Condition, Specify: Store in a cool (at max. 25°C / 77°F), dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 609a2a2f-594a-456e-b372-574073d9a206
Public Version Date: January 30, 2025
Public Version Number: 2
DI Record Publish Date: December 06, 2018