CranioSculpt C-FORM25CC

GUDID 00813845020481

CranioSculpt Form 25cc

SKELETAL KINETICS LLC

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

• Primary Device ID: 00813845020481
• NIH Device Record Key: 8bf7b818-cff9-40f8-afe6-122f57b2c65e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CranioSculpt
• Version Model Number: C-FORM25CC
• Catalog Number: C-FORM25CC
• 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(972)677-4655
• Email: cs@skeletalkinetics.com
• Phone: +1(972)677-4655
• 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: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 Milliliter
• Total Volume: 25 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813845020481 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-06-29
• Device Publish Date: 2015-10-30

On-Brand Devices [CranioSculpt]

• 00813845020962: CranioSculpt CMF Bone Void Filler 25cc
• 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