Fastener Sleeve with Handle 2004-0001-01

GUDID 00816950027819

Fastener Sleeve with Handle

SMV SCIENTIFIC LLC

General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: 00816950027819
• NIH Device Record Key: 17fb76d8-c56e-4918-9647-b12c0cdd9703
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fastener Sleeve with Handle
• Version Model Number: 2004-0001-01
• Catalog Number: 2004-0001-01
• 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: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com
• Phone: 1800-969-0639
• Email: info@osteocentric.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950027819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170021

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

[00816950027819]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-12
• Device Publish Date: 2020-06-17

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• 00810074300032 - 4.0 x 18mm Screw Super Fastener, ST: 2023-06-20 4.0 x 18mm Screw Super Fastener, ST
• 00810074300049 - 4.0 x 20mm Screw Super Fastener, ST: 2023-06-20 4.0 x 20mm Screw Super Fastener, ST
• 00810074300056 - 4.0 x 22mm Screw Super Fastener, ST: 2023-06-20 4.0 x 22mm Screw Super Fastener, ST
• 00810074300063 - 4.0 x 24mm Screw Super Fastener, ST: 2023-06-20 4.0 x 24mm Screw Super Fastener, ST
• 00810074300070 - 4.0 x 26mm Screw Super Fastener, ST: 2023-06-20 4.0 x 26mm Screw Super Fastener, ST