Stern IC Surgical Kit

GUDID 08415491139313

The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure.

STERNGOLD DENTAL LLC

Dental/maxillofacial surgical procedure kit, medicated, reusable

• Primary Device ID: 08415491139313
• NIH Device Record Key: f7430f63-1274-41c2-bff1-815340630539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern IC Surgical Kit
• Version Model Number: 905728
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL 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: true
• 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: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08415491139313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111798

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

[08415491139313]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-07-05

On-Brand Devices [Stern IC Surgical Kit]

• 08415491139313: The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone
• 00841549115264: The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone