Klassic Tibial Insert, Ultra-PS, E-Link Poly

GUDID 00814703014703

Tibial Insert, Ultra-PS, E-Link Poly, size 6, 10mm

TOTAL JOINT ORTHOPEDICS, INC.

Tibial insert

• Primary Device ID: 00814703014703
• NIH Device Record Key: 2c12e33a-2aaf-404e-8e6b-42b30e97d425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert, Ultra-PS, E-Link Poly
• Version Model Number: 5303.06.010
• 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 Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703014703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180159

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

[00814703014703]

Ethylene Oxide

[00814703014703]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-29

On-Brand Devices [Klassic Tibial Insert, Ultra-PS, E-Link Poly ]

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• 00814703014581: Tibial Insert, Ultra-PS, E-Link Poly, size 4, 12mm
• 00814703014574: Tibial Insert, Ultra-PS, E-Link Poly, size 4, 11mm
• 00814703014567: Tibial Insert, Ultra-PS, E-Link Poly, size 4, 10mm
• 00814703014550: Tibial Insert, Ultra-PS, E-Link Poly, size 3, 18mm
• 00814703014543: Tibial Insert, Ultra-PS, E-Link Poly, size 3, 16mm
• 00814703014536: Tibial Insert, Ultra-PS, E-Link Poly, size 3, 14mm
• 00814703014529: Tibial Insert, Ultra-PS, E-Link Poly, size 3, 13mm
• 00814703014512: Tibial Insert, Ultra-PS, E-Link Poly, size 3, 12mm
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• 00814703014482: Tibial Insert, Ultra-PS, E-Link Poly, size 2, 18mm
• 00814703014475: Tibial Insert, Ultra-PS, E-Link Poly, size 2, 16mm
• 00814703014468: Tibial Insert, Ultra-PS, E-Link Poly, size 2, 14mm
• 00814703014451: Tibial Insert, Ultra-PS, E-Link Poly, size 2, 13mm
• 00814703014444: Tibial Insert, Ultra-PS, E-Link Poly, size 2, 12mm
• 00814703014437: Tibial Insert, Ultra-PS, E-Link Poly, size 2, 11mm
• 00814703014420: Tibial Insert, Ultra-PS, E-Link Poly, size 2, 10mm
• 00814703014413: Tibial Insert, Ultra-PS, E-Link Poly, size 1, 18mm
• 00814703014406: Tibial Insert, Ultra-PS, E-Link Poly, size 1, 16mm
• 00814703014390: Tibial Insert, Ultra-PS, E-Link Poly, size 1, 14mm
• 00814703014383: Tibial Insert, Ultra-PS, E-Link Poly, size 1, 13mm
• 00814703014376: Tibial Insert, Ultra-PS, E-Link Poly, size 1, 12mm
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