GRAFTYS® QUICKSET KIT QSMKITUSV1Q8

GUDID 03760177571402

Injectable Macroporous Calcium Phosphate

GRAFTYS

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 03760177571402
• NIH Device Record Key: e83152b3-3bd5-4f20-a405-cee2d9226974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFTYS® QUICKSET KIT
• Version Model Number: 8cc
• Catalog Number: QSMKITUSV1Q8
• Company DUNS: 280930053
• Company Name: GRAFTYS
• 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: 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: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM
• Phone: +33442603000
• Email: CONTACT@GRAFTYS.COM

Device Dimensions

• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760177571402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093343

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20

On-Brand Devices [GRAFTYS® QUICKSET KIT]

• 03760177571419: Injectable Macroporous Calcium Phosphate
• 03760177571402: Injectable Macroporous Calcium Phosphate
• 03760177571396: Injectable Macroporous Calcium Phosphate