Aequalis™ Humeral Nail

GUDID 00846832017188

TORNIER, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00846832017188
• NIH Device Record Key: 771eb386-413a-44c1-afe5-ae7921ada7dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aequalis™ Humeral Nail
• Version Model Number: 7525032
• Company DUNS: 968990812
• Company Name: TORNIER, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 32 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832017188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082754

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[00846832017188]

Moist Heat or Steam Sterilization

[00846832017188]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-29

On-Brand Devices [Aequalis™ Humeral Nail]

• 00846832017287: 7424532
• 00846832017270: 7424530
• 00846832017263: 7424528
• 00846832017256: 7424526
• 00846832017249: 7424524
• 00846832017232: 7424522
• 00846832017225: 7424520
• 00846832017218: 7525064
• 00846832017201: 7525048
• 00846832017195: 7525036
• 00846832017188: 7525032
• 00846832017171: 7425056
• 00846832017164: 7425052
• 00846832017157: 7425048
• 00846832017140: 7425044
• 00846832017133: 7425040
• 00846832017126: 7425036
• 00846832017119: 7425032
• 00846832017102: 7425028
• 00846832017096: 7525060
• 00846832017089: 7525056
• 00846832017072: 7525052
• 00846832017065: 7525044
• 00846832017058: 7525040
• 00846832017041: 7525028
• 00846832017034: 7525024
• 00846832002276: 0020600
• 00846832002269: 0020500