ClearFit 171713

GUDID 00855113008036

Extra Large Static Cranial Implant (Primary and Backup

LONGEVITI NEURO SOLUTIONS LLC

Cranial resinous compound

• Primary Device ID: 00855113008036
• NIH Device Record Key: 752ade98-05f4-4c42-acab-85acbd9ba10f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearFit
• Version Model Number: 171713
• Catalog Number: 171713
• Company DUNS: 070659539
• Company Name: LONGEVITI NEURO SOLUTIONS 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 410-527-1803
• Email: info@longeviti.com

Device Dimensions

• Area/Surface Area: 60 Square centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *See special handling instructions
• Special Storage Condition, Specify: Between 0 and 0 *See special handling instructions
• Special Storage Condition, Specify: Between 0 and 0 *See special handling instructions
• Special Storage Condition, Specify: Between 0 and 0 *See special handling instructions

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855113008036 [Primary]
GS1	10855113008033 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170410

FDA Product Code

• PJN: Filler, Bone Void, Non-Alterable Compound For Cranioplasty

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: 2018-12-24
• Device Publish Date: 2018-11-21

On-Brand Devices [ClearFit]

• 00855113008043: Complex Static Cranial Implant (Primary and Backup)
• 00855113008036: Extra Large Static Cranial Implant (Primary and Backup
• 00855113008029: Large Static Cranial Implant (Primary and Backup)
• 00855113008012: Medium Static Cranial Implant (Primary and Backup)
• 00855113008005: Small Static Cranial Implant (Primary and Backup)
• 90855113008084: Extra Small Flat
• 00855113008098: Extra Small Curved
• 00855113008555: ClearFit OTS Disc Curved X-Large
• 00855113008548: ClearFit OTS Disc Curved Large
• 00855113008500: ClearFit OTS 2.4cm Cover with Slot
• 00855113008494: ClearFit OTS 2.4cm Cover
• 00855113008296: ClearFit OTS Chiari Extra Small (22)
• 00855113008289: ClearFit OTS Chiari Small (35)
• 00855113008272: ClearFit OTS Chiari Small (22)
• 00855113008159: ClearFit OTS Hemi Left
• 00855113008142: ClearFit OTS Cover - 3cm
• 00855113008135: ClearFit Hemi OTS Right
• 00855113008128: ClearFit OTS Cover - 2cm with slot
• 00855113008111: ClearFit OTS Cover - 2cm
• 00855113008104: ClearFit VDI
• 00855113008623: ClearFit Cover 2.1 (9mm thick)
• 00855113008562: ClearFit Cover 2.0 (5.7mm thick)
• 00855113008722: ClearFit 1.4cm Cover with Slot
• 00855113008715: ClearFit 1.4cm Cover
• 00855113008746: ClearFit large for international sales
• 00855113008739: ClearFit complex for international sales
• 00855113008197: ClearFit X-Large for international sales
• 00855113008173: ClearFit medium for international sales
• 00855113008166: ClearFit small for international sales