Fixation Screw 1000-19

GUDID 00841307126037

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00841307126037
• NIH Device Record Key: 8c7eae18-5684-44a3-916f-d4da43ca6752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation Screw
• Version Model Number: 1000-19
• Catalog Number: 1000-19
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 2
• 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: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841307126037 [Unit of Use]
GS1	10841307126034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090234

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

[00841307126037]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [Fixation Screw]

• 00841307126228: 1000-42
• 00841307126211: 1000-41
• 00841307126129: 1000-28
• 00841307126082: 1000-23
• 00841307126075: 1000-22
• 00841307126037: 1000-19
• 00841307129502: 1000-06
• 00841307129557: 1000-15