ENDOSKELETON® Sterile Barrier System 1130-1020

GUDID 00191375011965

Caddy, Medium

TITAN SPINE, LLC

Instrument tray

• Primary Device ID: 00191375011965
• NIH Device Record Key: 6a5d4876-6368-4c1e-a3a1-99a2a286b906
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® Sterile Barrier System
• Version Model Number: 1130-1020
• Catalog Number: 1130-1020
• Company DUNS: 623316978
• Company Name: TITAN SPINE, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com

Device Dimensions

• Length: 23 Inch
• Width: 13.5 Inch
• Device Size Text, specify: 0
• Height: 6.5 Inch
• Length: 23 Inch
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Length: 23 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375011965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142589

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

[00191375011965]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-23
• Device Publish Date: 2016-12-15

On-Brand Devices [ENDOSKELETON® Sterile Barrier System]

• 00191375028284: Soft Caddy, Medium
• 00191375011972: Caddy, Large
• 00191375011965: Caddy, Medium
• 00191375011958: Caddy, Small