Exact SSI004283

GUDID 00887868259838

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00887868259838
• NIH Device Record Key: 3897f133-5c46-4434-b29d-d9ac1460cd41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exact
• Version Model Number: SSI004283
• Catalog Number: SSI004283
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868259838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800144

FDA Product Code

• JDS: Nail, Fixation, Bone

Sterilization

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

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

[00887868259838]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-08-22

On-Brand Devices [Exact]

• 00880304432710: 31-555588
• 00887868259838: SSI004283