BIOSTOP 546312000

GUDID 10603295174561

BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12

DEPUY (IRELAND)

Polymer orthopaedic cement restrictor, bioabsorbable

• Primary Device ID: 10603295174561
• NIH Device Record Key: d8e22e77-b62a-44c0-b759-2b58e54592ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOSTOP
• Version Model Number: 5463-12-000
• Catalog Number: 546312000
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295174561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943727

FDA Product Code

• LZN: CEMENT OBTURATOR

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: 2019-07-19
• Device Publish Date: 2015-09-24

On-Brand Devices [BIOSTOP]

• 10603295174592: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 18
• 10603295174585: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 16
• 10603295174578: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 14
• 10603295174561: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12
• 10603295174554: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 10
• 10603295174547: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 8