Norian 07704010S

GUDID H67907704010S0

NORIAN DRILLABLE INJECT 10CC-STERILE

Synthes GmbH

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: H67907704010S0
• NIH Device Record Key: e2a2888d-4d75-4ee1-bb0c-6d74e0a294d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norian
• Version Model Number: 07.704.010S
• Catalog Number: 07704010S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *.
• Handling Environment Temperature: Between 0 and 43 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982131621 [Primary]
HIBCC	H67907704010S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073303

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-04-29
• Device Publish Date: 2015-09-14

On-Brand Devices [Norian]

• H67907704110S0: NORIAN DRILLABLE FAST SET PUTTY 10CC-STERILE
• H67907704105S0: NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE
• H67907704103S0: NORIAN DRILLABLE FAST SET PUTTY 3CC-STERILE
• H67907704010S0: NORIAN DRILLABLE INJECT 10CC-STERILE
• H67907704005S0: NORIAN DRILLABLE INJECT 5CC-STERILE
• H67907704003S0: NORIAN DRILLABLE INJECT 3CC-STERILE