OsteoMed 390-6010

GUDID 00842528100189

OsteoVation RM-EX, 10cc

SKELETAL KINETICS LLC

Bone matrix implant, synthetic

• Primary Device ID: 00842528100189
• NIH Device Record Key: d588d4f0-8c39-4392-99de-1d64a9f0e7d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoMed
• Version Model Number: 390-6010
• Catalog Number: 390-6010
• 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(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	00842528100189 [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: 2016-10-13

On-Brand Devices [OsteoMed]

• 00842528104156: OsteoVation RM-EX Inject, Bone Void Filler, 3cc
• 00842528100189: OsteoVation RM-EX, 10cc
• 00842528100172: OsteoVation RM-EX, 5cc