BladeX Center Shaft 202-0002

GUDID 00810097800922

BladeX Center Shaft

SMV SCIENTIFIC LLC

Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00810097800922
• NIH Device Record Key: 50f855fe-e541-4418-a1c4-2e3309ac76a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BladeX Center Shaft
• Version Model Number: 202-0002
• Catalog Number: 202-0002
• Company DUNS: 089645059
• Company Name: SMV SCIENTIFIC LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00810097800922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230226

FDA Product Code

• GES: Blade, Scalpel
• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

[00810097800922]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-16

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• 00810074300018 - 4.0 x 14mm Screw Super Fastener, ST: 2023-06-20 4.0 x 14mm Screw Super Fastener, ST
• 00810074300025 - 4.0 x 16mm Screw Super Fastener, ST: 2023-06-20 4.0 x 16mm Screw Super Fastener, ST
• 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