OsteoCentric Headless Compression System Obturator EX01-0005

GUDID 00850015496295

Headless Compression System Obturator

SMV SCIENTIFIC LLC

Surgical drill guide obturator

• Primary Device ID: 00850015496295
• NIH Device Record Key: dc7bc34c-05e0-4924-87ac-48b7febae76c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoCentric Headless Compression System Obturator
• Version Model Number: EX01-0005
• Catalog Number: EX01-0005
• 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: false
• Lot Batch: false
• 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: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com
• Phone: 1 800-969-0639
• Email: quality@osteocentric.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015496295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200259

FDA Product Code

• FZX: Guide, Surgical, Instrument
• HWC: Screw, Fixation, Bone

Sterilization

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

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

[00850015496295]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-23
• Device Publish Date: 2023-02-15

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• 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