Hi-Fi HT7150

GUDID 20653405005480

2MM Hi-Fi® Tape White/Black

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 20653405005480
• NIH Device Record Key: 83eb2c05-bfad-4dd9-be1e-8770e17bf6e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hi-Fi
• Version Model Number: HT7150
• Catalog Number: HT7150
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 12
• 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(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Dimensions

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405005486 [Unit of Use]
GS1	10653405005483 [Primary]
GS1	20653405005480 [Package]; Contains: 10653405005483; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100006

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-21
• Device Publish Date: 2021-10-13

On-Brand Devices [Hi-Fi]

• 20653405002045: HiFi SUTURE WITH DOUBLE ARMED MENISCAL NEEDLES
• 20653405005497: Hi-Fi® Passing Loop
• 20653405005480: 2MM Hi-Fi® Tape White/Black
• 20653405005473: 2MM Hi-Fi® Tape Blue