PROGENIX® PUTTY and PROGENIX® PLUS

GUDID 00613994391049

DBM 006010 PROGENIX PLUS 10CC

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00613994391049
• NIH Device Record Key: 48a86f7f-90c5-4ba0-98be-f6e5b9b06485
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROGENIX® PUTTY and PROGENIX® PLUS
• Version Model Number: 006010
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at ambient temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994391049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081950

FDA Product Code

• NUN: BONE GRAFTING MATERIAL, HUMAN SOURCE

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: 2015-07-20

On-Brand Devices [PROGENIX® PUTTY and PROGENIX® PLUS]

• 00613994391049: DBM 006010 PROGENIX PLUS 10CC
• 00613994391032: DBM 006005 PROGENIX PLUS 5CC
• 00613994391025: DBM 006002 PROGENIX PLUS 2.5CC
• 00613994391018: DBM 006001 PROGENIX PLUS 1CC
• 00613994236425: DBM 005005 PROGENIX DBM 5 CC SRVC FEE
• 00613994236418: DBM 005001 PROGENIX DBM 1CC SRVC FEE
• 00613994236401: DBM 000505 PRGENIX 0.5CC SRVC FEE
• 00613994247612: DBM 005110 PRGENIX DBM 10 CC SRVC FEE