nanOss® 3D Plus™ 90-400-251008

GUDID 00846468087128

resorbable porous calcium phosphate bone void filler 25 x 100 x 8mm; 20 cc

Pioneer Surgical Technology, Inc.

Bone matrix implant, composite

• Primary Device ID: 00846468087128
• NIH Device Record Key: aa644dd0-7d1a-478b-96a6-1e24bb7de9b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nanOss® 3D Plus™
• Version Model Number: 90-400-251008
• Catalog Number: 90-400-251008
• Company DUNS: 793384496
• Company Name: Pioneer Surgical 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: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com
• Phone: +1(386)418-8888
• Email: Labeling@rtix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468087128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132050

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: 2
• Public Version Date: 2019-06-13
• Device Publish Date: 2018-09-19

On-Brand Devices [nanOss® 3D Plus™]

• 00846468087135: resorbable porous calcium phosphate bone void filler 25 x 100 x 4mm; 10cc
• 00846468087128: resorbable porous calcium phosphate bone void filler 25 x 100 x 8mm; 20 cc
• 00846468087111: resorbable porous calcium phosphate bone void filler 25 x 50 x 8mm; 10 cc
• 00846468087104: resorbable porous calcium phosphate bone void filler 25 x 50 x 4mm; 5 cc