BIORAPTOR / ULTRABRAID 72201702

GUDID 03596010607553

BIRAPTR 2.9 AB SUTURE ANCR TWO 38 U/B

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03596010607553
• NIH Device Record Key: 664b9c99-0b32-405a-adf7-40a6084880a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIORAPTOR / ULTRABRAID
• Version Model Number: 72201702
• Catalog Number: 72201702
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010607553 [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: 2015-09-21

On-Brand Devices [BIORAPTOR / ULTRABRAID]

• 00885554014112: BIORAPTOR 2.9 STR ANCHOR PCK 2 ULTRBRD
• 00885554013573: BIORAPTOR 2.9 SUTURE ANCHOR PACK 1 ULTBR
• 03596010656469: BIORAPTOR CRV 2.3 PK SA UB COBRD BLUE
• 03596010656452: BIORAPTOR CRV 2.3 PK SA UB COBRD BLACK
• 03596010595096: BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB WTE
• 03596010595089: BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB BLK
• 03596010595072: BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB
• 03596010607553: BIRAPTR 2.9 AB SUTURE ANCR TWO 38 U/B