PROGENIX™ PUTTY and PROGENIX™ PLUS

GUDID 00763000140540

DBM 006001 PROGENIX PLUS PUTTY 1CC

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: 00763000140540
• NIH Device Record Key: 0b829f75-d556-49d7-a3cc-ff78c543ef34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROGENIX™ PUTTY and PROGENIX™ PLUS
• Version Model Number: 006001
• 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: true
• Serial Number: false
• 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	00763000140540 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

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

• 00763000140571: DBM 006010 PROGENIX PLUS PUTTY 10CC
• 00763000140564: DBM 006005 PROGENIX PLUS PUTTY 5CC
• 00763000140557: DBM 006002 PROGENIX PLUS PUTTY 2.5CC
• 00763000140540: DBM 006001 PROGENIX PLUS PUTTY 1CC
• 00763000140533: DBM 005110 PROGENIX PUTTY 10CC
• 00763000140526: DBM 005005 PROGENIX PUTTY 5CC
• 00763000140519: DBM 005001 PROGENIX PUTTY 1CC
• 00763000140502: DBM 000505 PROGENIX PUTTY .5CC