FastFrame™ 47-5300-030-00

GUDID 00889024561984

Zimmer, Inc.

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 00889024561984
• NIH Device Record Key: a5829f28-72fa-49c8-b9d1-39f926570011
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastFrame™
• Version Model Number: 47-5300-030-00
• Catalog Number: 47-5300-030-00
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024561984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151992

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-14

On-Brand Devices [FastFrame™]

• 00889024561991: 47-5300-050-00
• 00889024561984: 47-5300-030-00
• 00889024561977: 00-5300-050-01
• 00889024508576: 00-5300-050-01
• 00889024464117: 47-5300-070-01
• 00889024464100: 47-5300-010-01
• 00889024464094: 47-5300-050-01
• 00889024464087: 47-5300-070-00
• 00889024464070: 47-5300-010-00
• 00889024464063: 47-5300-030-00
• 00889024464056: 47-5300-050-00