Klassic HD Hooded Acetabular Insert with E-Link Poly

GUDID 00814703015113

Hooded Acetabular Insert with E-Link Poly, 22mm head, size 46mm

TOTAL JOINT ORTHOPEDICS, INC.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00814703015113
• NIH Device Record Key: 96e76f5b-70c3-40af-834b-8a2fb5209a70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic HD Hooded Acetabular Insert with E-Link Poly
• Version Model Number: 3507.46.022
• Company DUNS: 078416717
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• 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: true
• 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(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703015113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180929

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

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

[00814703015113]

Ethylene Oxide

[00814703015113]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-13
• Device Publish Date: 2018-06-12

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