OsteoVation 390-6001

GUDID 00813845021082

OsteoVation RMx Injectable Bone Void Filler

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: 00813845021082
• NIH Device Record Key: d9e1fa52-ca13-48cc-985b-b14f927b25d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoVation
• Version Model Number: 390-6001
• Catalog Number: 390-6001
• 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: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 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	00813845021082 [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: 2016-02-09

On-Brand Devices [OsteoVation]

• 00813845021099: OsteoVation RMx Injectable Bone Void Filler
• 00813845021082: OsteoVation RMx Injectable Bone Void Filler
• 00813845020214: OsteoVation ßTCP, 12cc
• 00813845020207: OsteoVation ßTCP, 6cc
• 00813845020184: OsteoVation QWIK, Impact, 10cc
• 00813845020177: OsteoVation QWIK, Impact, 5cc
• 00813845020160: OsteoVation QWIK, Impact, 3cc
• 00813845020153: OsteoVation QWIK, Impact, 2cc
• 00813845020146: OsteoVation QWIK, Inject, 10cc
• 00813845020139: OsteoVation QWIK, Inject, 5cc
• 00813845020122: OsteoVation QWIK, Inject, 3cc
• 00813845020115: OsteoVation QWIK, Inject, 2cc
• 00813845020092: OsteoVation, Impact 10cc
• 00813845020085: Osteovation, Impact 5cc
• 00813845020078: OsteoVation, Impact 3cc
• 00813845020061: OsteoVation, Inject 10cc
• 00813845020054: OsteoVation, Inject 5cc
• 00813845020047: OsteoVation EX Impact 5cc
• 00813845020030: OsteoVation EX Impact 3cc
• 00813845020023: OsteoVation EX Inject 5cc
• 00813845020016: OsteoVation EX Inject 3cc
• 00813845020009: OsteoVation EX Inject 2cc