PLEXUR P®

GUDID 00643169218130

WEDGE 60000215INT PLEXUR P 40MMX15MMX15

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00643169218130
• NIH Device Record Key: 8a8f8d50-37b8-47d1-90a8-53479c962174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLEXUR P®
• Version Model Number: 60000215INT
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169218130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080511

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-02

On-Brand Devices [PLEXUR P®]

• 00613994986672: GRANULES 6000-010 PLEXUR P 10CC
• 00613994986665: GRANULES 6000-020 PLEXUR P 20CC
• 00613994986658: GRANULES 6000-030 PLEXUR P 30CC
• 00613994986641: CYLINDER 6000-107 PLEXUR P 7MMX25MM
• 00613994986634: CYLINDER 6000-109 PLEXUR P 9MMX25MM
• 00613994986627: CYLINDER 6000-111 PLEXUR P 11MMX25MM
• 00613994986610: WEDGE 6000-210 PLEXUR P 40MMX15MMX10 DEG
• 00613994986603: WEDGE 6000-215 PLEXUR P 40MMX15MMX15 DEG
• 00613994986597: BLOCK 6000-310 PLEXUR P 10MMX10MMX20MM
• 00613994986580: BLOCK 6000-320 PLEXUR P 20MMX20MMX20MM
• 00613994986573: SHEET 6000-425 PLEXUR P 50MMX25MMX4MM
• 00613994986566: SHEET 6000-525 PLEXUR P 100MMX25MMX4MM
• 00643169218307: GRANULES 60000005 PLEXUR P 5CC
• 00643169218284: GRANULES 60000010 PLEXUR P 10CC
• 00643169218277: GRANULES 60000010INT PLEXUR P 10CC
• 00643169218260: GRANULES 60000020 PLEXUR P 20 CC
• 00643169218253: GRANULES 60000020INT PLEXUR P 20 CC
• 00643169218246: GRANULES 60000030 PLEXUR P 30 CC
• 00643169218239: GRANULES 60000030INT PLEXUR P 30 CC
• 00643169218222: CYLINDER 60000107 PLEXUR P 7MMX25MM
• 00643169218208: CYLINDER 60000109 PLEXUR P 9MMX25MM
• 00643169218185: CYLINDER 60000111 PLEXUR P 11MMX25MM
• 00643169218161: WEDGE 60000210 PLEXUR P 40MMX15MMX10
• 00643169218147: WEDGE 60000215 PLEXUR P 40MMX15MMX15
• 00643169218130: WEDGE 60000215INT PLEXUR P 40MMX15MMX15
• 00643169218123: BLOCK 60000310 PLEXUR P 10MMX10MMX20MM
• 00643169218116: BLCK 60000310INT PLEXUR P 10MMX10MMX20MM
• 00643169218109: BLOCK 60000320 PLEXUR P 20MMX20MMX20MM
• 00643169218093: BLCK 60000320INT PLEXUR P 20MMX20MMX20MM
• 00643169218086: SHEET 60000425 PLEXUR P 50MMX25MMX4MM
• 00643169218062: SHEET 60000525 PLEXUR P 100MMX25MMX4MM