BioPrep 0206710000

GUDID 34546540039638

Bone Preparation Kit

STRYKER CORPORATION

Orthopaedic cement, non-medicated

• Primary Device ID: 34546540039638
• NIH Device Record Key: b902d0af-b218-4a97-9454-beffacffb400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPrep
• Version Model Number: 0206710000
• Catalog Number: 0206710000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• 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)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540039637 [Primary]
GS1	34546540039638 [Package]; Contains: 04546540039637; Package: pack [6 Units]; In Commercial Distribution

FDA Product Code

• JDK: Prosthesis, hip, cement restrictor

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: 2015-09-23

Devices Manufactured by STRYKER CORPORATION

• 07613327262995 - XIA II: 2025-07-17 CORONAL BENDER LEFT
• 07613327263015 - XIA II: 2025-07-17 CORONAL BENDER RIGHT
• 07613327661989 - KNOTILUS+: 2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327661996 - KNOTILUS+: 2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
• 07613327662009 - KNOTILUS+: 2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327662016 - KNOTILUS+: 2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
• 07613327662023 - KNOTILUS+: 2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327662030 - ALPHAVENT: 2025-06-24 ALPHAVENT KNOTLESS SP, 4.75MM, BIOCOMPOSITE ANCHOR