CranioSculpt C-C10CC

GUDID 00813845021129

CranioSculpt C 10cc

SKELETAL KINETICS LLC

Bone matrix implant, synthetic

• Primary Device ID: 00813845021129
• NIH Device Record Key: d88400d2-a749-42c8-8267-f1109adec6e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CranioSculpt
• Version Model Number: C-C10CC
• Catalog Number: C-C10CC
• Company DUNS: 140071411
• Company Name: SKELETAL KINETICS LLC
• Device Count: 1
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com
• Phone: +1(408)366-5014
• Email: cs@skeletalkinetics.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813845021129 [Primary]

FDA Product Code

• GXP: METHYL METHACRYLATE FOR CRANIOPLASTY

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: 2019-12-25
• Device Publish Date: 2019-12-17

On-Brand Devices [CranioSculpt]

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• 00813845020955: CranioSculpt CMF Bone Void Filler 10cc
• 00813845020948: CranioSculpt Flow 5cc
• 00813845020931: CranioSculpt Flow 3cc
• 00813845020498: CranioSculpt Form, CAN, 25cc
• 00813845020481: CranioSculpt Form 25cc
• 00813845020474: CranioSculpt Form OUS, 10cc
• 00813845020467: CranioSculpt Form, CAN, 10cc
• 00813845020450: CranioSculpt Form 10cc
• 00813845020443: CranioSculpt Form OUS, 5cc
• 00813845020436: CranioSculpt Form, CAN, 5cc
• 00813845020429: CranioSculpt Form 5cc
• 00813845020412: CranioSculpt Form 3cc
• 00813845020405: CranioSculpt Flow, CAN, 25cc
• 00813845020399: CranioSculpt Flow 25cc
• 00813845020382: CranioSculpt Flow OUS 10cc
• 00813845020375: CranioSculpt Flow, CAN, 10cc
• 00813845020368: CranioSculpt Flow 10cc
• 00813845020351: CranioSculpt Form OUS, 5cc
• 00813845020344: CranioSculpt Form, CAN, 5cc
• 00813845020337: CranioSculpt Form 5cc
• 00813845020320: CranioSculpt Form 3cc
• 00813845021129: CranioSculpt C 10cc
• 00813845021112: CranioSculpt C 5cc
• 00813845021105: CranioSculpt C 3cc