STRIDE Unicondylar Kne

GUDID 00841153100137

STRIDE Tibial Tray Implant SIZE 7 LM/RL

BLUE BELT TECHNOLOGIES, INC.

Uncoated unicondylar knee tibia prosthesis, metallic

• Primary Device ID: 00841153100137
• NIH Device Record Key: c8ece0fc-cac4-469f-8aee-edf8ad489aee
• Commercial Distribution Discontinuation: 2016-12-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: STRIDE Unicondylar Kne
• Version Model Number: 110036
• Company DUNS: 015299627
• Company Name: BLUE BELT TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 763-452-4910
• Email: customersupport@bluebelttech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841153100137 [Primary]

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

Devices Manufactured by BLUE BELT TECHNOLOGIES, INC.

• 00841153100007 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 1 RM/LL
• 00841153100014 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 1 LM/RL
• 00841153100021 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 2 RM/LL
• 00841153100038 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 2 LM/RL
• 00841153100045 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 3 RM/LL
• 00841153100052 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 3 LM/RL
• 00841153100069 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 4 RM/LL
• 00841153100076 - STRIDE Unicondylar Knee: 2018-03-29 STRIDE Tibial Tray Implant SIZE 4 LM/RL