AccessGUDID - DEVICE: PLEXUR P® (00643169218246)

GUDID

Device Identifier (DI) Information

Brand Name: PLEXUR P®
Version or Model: 60000030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169218246
Issuing Agency: GS1
Commercial Distribution End Date: October 08, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: GRANULES 60000030 PLEXUR P 30 CC

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61403	Cadaveric-donor/synthetic polymer bone graft	A sterile implantable device consisting of processed cadaveric human bone (allograft) mixed with bioabsorbable synthetic polymers, intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is available as granules or various solid shapes in a variety of sizes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBP	Filler, bone void, osteoinduction (w/o human growth factor)
MQV	FILLER, BONE VOID, CALCIUM COMPOUND

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080511	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30cc volume

Device Record Status

Public Device Record Key: 86065e20-7bdb-4ba0-8479-0d0a2842fbf2
Public Version Date: February 21, 2019
Public Version Number: 4
DI Record Publish Date: July 20, 2015