CANCELLO-PURE

GUDID 00840420136930

WRIGHT MEDICAL TECHNOLOGY, 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 Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: 00840420136930
• NIH Device Record Key: 9d7c634b-6b4c-40a5-a48f-59117f2e8225
• Commercial Distribution Discontinuation: 2015-11-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CANCELLO-PURE
• Version Model Number: 46660012
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: true
• 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)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420136930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072327

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: 2015-10-15

On-Brand Devices [CANCELLO-PURE]

• 00840420136947: 46620006
• 00840420136930: 46660012
• 00889797015363: 46660200
• 00889797015431: 46661200
• 00889797015417: 46661000
• 00889797015394: 46660800