RapidEase™ 4561SC

GUDID 00191083047683

Single Strand Pre-Sutured Tendon

Rti Surgical, Inc.

Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft Tendon graft

• Primary Device ID: 00191083047683
• NIH Device Record Key: f80886e1-e11b-464f-9e8c-86df2c7e23f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapidEase™
• Version Model Number: 4561SC
• Catalog Number: 4561SC
• Company DUNS: 117560455
• Company Name: Rti Surgical, 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.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
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)
• Special Storage Condition, Specify: Between 0 and 0 *Frozen (-40C(-40F) or less to exp)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083047683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230036

FDA Product Code

• GAT: Suture, nonabsorbable, synthetic, polyethylene

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-13
• Device Publish Date: 2023-11-03

On-Brand Devices [RapidEase™]

• 00191083047683: Single Strand Pre-Sutured Tendon
• 00191083047676: Quadruple Strand Pre-Sutured Tendon