HYDROSET 397010

GUDID 07613154272129

Hydroset Injectable HA Bone Subst.10cc

Stryker Leibinger GmbH & Co. KG

Bone matrix implant, synthetic

• Primary Device ID: 07613154272129
• NIH Device Record Key: 63a71474-1f77-4187-9eb6-a62d4384657a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDROSET
• Version Model Number: 397010
• Catalog Number: 397010
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154272129 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

On-Brand Devices [HYDROSET]

• 07613154888153: 8GAX10CM TEN CURVED CANNULAE PACK
• 07613154804788: 8GAX10CM TEN CANNULAE PACK
• 07613154804771: 10GAX10CM TEN CANNULAE PACK
• 07613154804764: 12GAX7.5CM TEN CANNULAE PACK
• 07613154275021: 15CC HYDROSET INJECTABLE CEMENT
• 07613154275014: 10CC HYDROSET INJECTABLE CEMENT
• 07613154275007: 5CC HYDROSET INJECTABLE CEMENT
• 07613154274994: 3CC HYDROSET INJECTABLE CEMENT
• 07613154272136: Hydroset Injectable HA Bone Subst.15cc
• 07613154272129: Hydroset Injectable HA Bone Subst.10cc
• 07613154272112: Hydroset Injectable HA Bone Subst. 5cc
• 07613154272105: Hydroset Injectable HA Bone Subst. 3cc