SpineSmith Fusionary Graft Delivery System 0861-0003

GUDID 00817771027408

Celling Injection Kit

Celling Biosciences

Bone graft syringe Bone graft syringe Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use Bone graft syringe, single-use

• Primary Device ID: 00817771027408
• NIH Device Record Key: 4b5cccf4-6745-4a6a-8bf4-789aa8dc1eda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineSmith Fusionary Graft Delivery System
• Version Model Number: 0861-0003
• Catalog Number: 0861-0003
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com
• Phone: 512-637-6745
• Email: CustomerService@CellingBiosciences.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817771027408 [Primary]

FDA Product Code

• KDD: Kit, Surgical Instrument, Disposable

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: 2018-03-29
• Device Publish Date: 2016-12-29

On-Brand Devices [SpineSmith Fusionary Graft Delivery System]

• 00817771027613: ART GFC Kit
• 00817771027408: Celling Injection Kit
• 00817771027392: 120cc: Graft Delivery Kit
• 00817771027385: Graft Delivery Kit
• 00817771027378: Blood Draw Kit
• 00817771027361: Small Volume Bone Marrow Aspiration Kit
• 00817771027354: Bone Marrow Aspiration Kit
• 00817771027347: BMA Kit Large Volume
• 00817771027330: BMA Kit Classic
• 00817771027323: BMA Kit Standard
• 00817771027316: BMA Kit with 30cc Syringes