3.3mm Interlocking Bone Screw Fastener 333-1028

GUDID 00816950025228

28mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping

SMV SCIENTIFIC LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00816950025228
• NIH Device Record Key: 946a3b63-2dfc-49aa-9b52-8c6a94207b7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.3mm Interlocking Bone Screw Fastener
• Version Model Number: 333-1028
• Catalog Number: 333-1028
• Company DUNS: 089645059
• Company Name: SMV SCIENTIFIC 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: 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: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com

Device Dimensions

• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950025228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150981

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00816950025228]

Moist Heat or Steam Sterilization

[00816950025228]

Moist Heat or Steam Sterilization

[00816950025228]

Moist Heat or Steam Sterilization

[00816950025228]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-20

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• 00816950025204: 24mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping
• 00816950025198: 22mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping
• 00816950025181: 20mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping
• 00816950025174: 18mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping
• 00816950025167: 16mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping
• 00816950025150: 14mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping
• 00816950025143: 10mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping
• 00816950025136: 12mm, 3.3mm Interlocking Bone Screw Fastener, Self-Tapping