Screw TX, dental TCT10 013

GUDID E0HM36TCT100131

Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 13mm, diameter 1.3mm, core diameter 1.0mm The bone screws have a self-tapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile.

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: E0HM36TCT100131
• NIH Device Record Key: 6f18cd40-0feb-4d36-a7bb-77c29b2d9362
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Screw TX, dental
• Version Model Number: TCT10 013
• Catalog Number: TCT10 013
• Company DUNS: 318034329
• Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung
• Device Count: 10
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (303) 268-5400
• Email: info@meisingerusa.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E0HM36TCT10013 [Unit of Use]
HIBCC	E0HM36TCT100131 [Primary]
HIBCC	E0HM36TCT100139 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132212

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[E0HM36TCT100131]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-14
• Device Publish Date: 2015-07-10

On-Brand Devices [Screw TX, dental]

• E0HM36TCT100161: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 1
• E0HM36TCT100131: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 1
• E0HM36TCT100101: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 1
• E0HM36TCT100071: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 7
• E0HM36TCT090161: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 1
• E0HM36TCT090131: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 1
• E0HM36TCT090101: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 1
• E0HM36TCT090071: Screw for fixation of bone segments e.g. for horizontal or vertical augmentative grafts Length 7