GDP-10 Graft Delivery System 10.1

GUDID 35020583514493

GDP-10 Graft Delivery Pack, 10:1

TERUMO BCT, INC.

Bone graft delivery kit

• Primary Device ID: 35020583514493
• NIH Device Record Key: 101ab122-6106-4418-b80e-23b03b4ef9a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GDP-10 Graft Delivery System 10.1
• Version Model Number: 51449
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 3
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583514492 [Unit of Use]
GS1	35020583514493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043261

FDA Product Code

• FMF: Syringe, piston

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: 2016-09-15

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