CRANIOS Reinforced 6160501S

GUDID H9806160501S0

CRANIOS REINFORCED ROTARY MIX 5CC-STERILE

SYNTHES (U.S.A.) LP

Bone matrix implant, synthetic

• Primary Device ID: H9806160501S0
• NIH Device Record Key: e41336e0-fe20-448b-b468-f18ed63d8f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRANIOS Reinforced
• Version Model Number: 616.05.01S
• Catalog Number: 6160501S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: false
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587058689 [Primary]
HIBCC	H9806160501S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102018

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [CRANIOS Reinforced]

• H9806161001S0: CRANIOS REINFORCED ROTARY MIX 10CC-STERILE
• H9806160501S0: CRANIOS REINFORCED ROTARY MIX 5CC-STERILE
• H9806160301S0: CRANIOS REINFORCED ROTARY MIX 3CC-STERILE
• H9806151001S0: CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE
• H9806150501S0: CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE
• H9806150301S0: CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE