AccessGUDID - DEVICE: KYPHON ELEMENT™ Balloon Kyphoplasty System (00643169582248)

GUDID

Device Identifier (DI) Information

Brand Name: KYPHON ELEMENT™ Balloon Kyphoplasty System
Version or Model: F25R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169582248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: BONE FILLER DEVICE F25R 3 VALUE BFD

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:	Yes
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?
35809	Orthopaedic cement dispenser	A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIH	DISPENSER, CEMENT

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8eea7328-aab1-4e98-ac2c-5855c6c1e2ec
Public Version Date: March 18, 2019
Public Version Number: 1
DI Record Publish Date: March 08, 2019