RapidEase™ 4561SC

GUDID 00191083047683

Single Strand Pre-Sutured Tendon

Rti Surgical, Inc.

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