AccessGUDID - DEVICE: Medtronic® Bone Void Filler (00643169110267)

GUDID

Device Identifier (DI) Information

Brand Name: Medtronic® Bone Void Filler
Version or Model: C07B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169110267
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: BONE VOID FILLER C07B LARGE VOLUME

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?
35217	Orthopaedic cement, non-antimicrobial	A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQV	FILLER, BONE VOID, CALCIUM COMPOUND

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 6308e8a5-f6e7-4422-9e42-c6ed825d2b1f
Public Version Date: June 03, 2025
Public Version Number: 5
DI Record Publish Date: September 01, 2015