STOMA® titanium bone screw 23053.08

GUDID ESAM23053081

STOMA® titanium bone screws Ø1,3 X 8mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. STOMA® titanium bone screws are delivered in non-sterile conditions.

Storz am Mark GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: ESAM23053081
• NIH Device Record Key: 5d9cf3b6-c9d3-4aef-b69e-4775f518d8ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STOMA® titanium bone screw
• Version Model Number: 23053.08
• Catalog Number: 23053.08
• Company DUNS: 318268125
• Company Name: Storz am Mark GmbH
• Device Count: 3
• DM Exempt: true
• 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: 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: 9999999999
• Email: sam@stoma.de

Device Dimensions

• Outer Diameter: 1.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ESAM23053080 [Unit of Use]
HIBCC	ESAM23053081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051871

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[ESAM23053081]

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: 2015-10-16

On-Brand Devices [STOMA® titanium bone screw]

• ESAM23053101: STOMA® titanium bone screws Ø1,3 X 10mm are developed and manufactured to be used as non-activ
• ESAM23053081: STOMA® titanium bone screws Ø1,3 X 8mm are developed and manufactured to be used as non-activ
• ESAM23053061: STOMA® titanium bone screws Ø1,3 X 6mm are developed and manufactured to be used as non-activ
• ESAM23053041: STOMA® titanium bone screws Ø1,3 X 4mm are developed and manufactured to be used as non-activ
• ESAM23052161: STOMA® titanium bone screws Ø2,0 X 16mm are developed and manufactured to be used as non-activ
• ESAM23052141: STOMA® titanium bone screws Ø2,0 X 14mm are developed and manufactured to be used as non-activ
• ESAM23052121: STOMA® titanium bone screws Ø2,0 X 12mm are developed and manufactured to be used as non-activ
• ESAM23052101: STOMA® titanium bone screws Ø2,0 X 10mm are developed and manufactured to be used as non-activ
• ESAM23052081: STOMA® titanium bone screws Ø2,0 X 8mm are developed and manufactured to be used as non-activ
• ESAM23051161: STOMA® titanium bone screws Ø1,6 X 16mm are developed and manufactured to be used as non-activ
• ESAM23051141: STOMA® titanium bone screws Ø1,6 X 14mm are developed and manufactured to be used as non-activ
• ESAM23051121: STOMA® titanium bone screws Ø1,6 X 12mm are developed and manufactured to be used as non-activ
• ESAM23051101: STOMA® titanium bone screws Ø1,6 X 10mm are developed and manufactured to be used as non-activ
• ESAM23051081: STOMA® titanium bone screws Ø1,6 X 8mm are developed and manufactured to be used as non-activ
• ESAM23051061: STOMA® titanium bone screws Ø1,6 X 6mm are developed and manufactured to be used as non-activ