BIOSTOP 546320000

GUDID 10603295174608

BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 20

DEPUY ORTHOPAEDICS, INC.

Polymer orthopaedic cement restrictor, bioabsorbable

• Primary Device ID: 10603295174608
• NIH Device Record Key: aac19cf1-2126-4b41-8dd2-162b46f66def
• Commercial Distribution Discontinuation: 2023-01-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOSTOP
• Version Model Number: 5463-20-000
• Catalog Number: 546320000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295174608 [Primary]

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: 6
• Public Version Date: 2024-11-26
• Device Publish Date: 2015-09-24

On-Brand Devices [BIOSTOP]

• 10603295174721: BIOSTOP G INSERTER T-HANDLE
• 10603295174714: BIOSTOP G CEMENT RESTRICTOR HOLDER 18/20mm
• 10603295174707: BIOSTOP G CEMENT RESTRICTOR HOLDER 14/16mm
• 10603295174691: BIOSTOP G CEMENT RESTRICTOR HOLDER 10/12mm
• 10603295174684: BIOSTOP G CEMENT RESTRICTOR HOLDER 8mm
• 10603295174738: BIOSTOP G CEMENT RESTRICTOR STERILIZATION CASE
• 10603295174677: BIOSTOP G CEMENT RESTRICTOR TRIAL 20mm
• 10603295174660: BIOSTOP G CEMENT RESTRICTOR TRIAL 18mm
• 10603295174653: BIOSTOP G CEMENT RESTRICTOR TRIAL 16mm
• 10603295174646: BIOSTOP G CEMENT RESTRICTOR TRIAL 14mm
• 10603295174639: BIOSTOP G CEMENT RESTRICTOR TRIAL 12mm
• 10603295174622: BIOSTOP G CEMENT RESTRICTOR TRIAL 10mm
• 10603295174615: BIOSTOP G CEMENT RESTRICTOR TRIAL 8mm
• 10603295174608: BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 20