BoneCam

GUDID 10818614020881

VALERIS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10818614020881
• NIH Device Record Key: b86a6004-73a7-481b-8918-1e017c950908
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BoneCam
• Version Model Number: 08-11109
• Company DUNS: 079444554
• Company Name: VALERIS MEDICAL 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614020884 [Primary]
GS1	10818614020881 [Package]; Contains: 00818614020884; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152255

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-08-17

On-Brand Devices [BoneCam]

• 10818614021253: 08-11126
• 10818614021192: 08-12120
• 10818614021185: 08-12119
• 10818614021178: 08-12118
• 10818614021161: 08-12117
• 10818614021154: 08-12116
• 10818614021147: 08-12115
• 10818614021130: 08-12114
• 10818614021123: 08-12113
• 10818614021116: 08-12112
• 10818614021109: 08-12111
• 10818614021093: 08-12110
• 10818614021086: 08-12109
• 10818614021079: 08-12108
• 10818614021062: 08-12107
• 10818614021055: 08-12106
• 10818614021048: 08-12105
• 10818614021031: 08-12104
• 10818614021024: 08-12103
• 10818614021017: 08-12102
• 10818614021000: 08-12101
• 10818614020997: 08-11120
• 10818614020980: 08-11119
• 10818614020973: 08-11118
• 10818614020966: 08-11117
• 10818614020959: 08-11116
• 10818614020942: 08-11115
• 10818614020935: 08-11114
• 10818614020928: 08-11113
• 10818614020911: 08-11112
• 10818614020904: 08-11111
• 10818614020898: 08-11110
• 10818614020881: 08-11109
• 10818614020874: 08-11108
• 10818614020867: 08-11107
• 10818614020850: 08-11106
• 10818614020843: 08-11105
• 10818614020836: 08-11104
• 10818614020799: 08-11103
• 10818614020782: 08-11102
• 10818614020775: 08-11101
• 00818614021553: BoneCam 3.1mm Drill
• 00818614021546: BoneCam 3.0mm Drill
• 00818614021539: BoneCam 2.7mm Drill
• 00818614021522: BoneCam 2.6mm Drill
• 00818614021515: BoneCam Drill 3.3mm
• 00818614021508: BoneCam 2.9mm Drill
• 00818614021560: BoneCam Angled Reusable Surgical Drill Guide