BIORAPTOR/ULTRABRAID 72200775

GUDID 03596010585967

BIORAPTOR 2.9 WITH 2 ULTRABRAID

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03596010585967
• NIH Device Record Key: 15aa9d8a-4d78-4de6-b8d2-07dafa7fa867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIORAPTOR/ULTRABRAID
• Version Model Number: 72200775
• Catalog Number: 72200775
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010585967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151105

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-11-08

On-Brand Devices [BIORAPTOR/ULTRABRAID]

• 03596010585967: BIORAPTOR 2.9 WITH 2 ULTRABRAID
• 03596010585950: BIORAPTOR 2.9 WITH 1 ULTRABRAID
• 03596010585943: BIORAPTOR 2.9 WITH DURABRAID