TWINFIX / ULTRABRAID 72202603

GUDID 03596010647597

TWINFIX ULTRA PLLA/HA 5.5 W/3 UB

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03596010647597
• NIH Device Record Key: fbaa27e5-a313-423e-87d1-54d843beb68d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TWINFIX / ULTRABRAID
• Version Model Number: 72202603
• Catalog Number: 72202603
• Company DUNS: 109903521
• 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)821-5700
• 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
• 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
• 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	03596010647597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151105

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

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: 2020-01-31
• Device Publish Date: 2015-09-21

On-Brand Devices [TWINFIX / ULTRABRAID]

• 00885554029277: TWINFIX 3.5 TITANIUM ANC W/ ULTB SUTURE W/NEED
• 00885554018691: TF ULTRA 2 UB AND NDLS 6.5MM PLLA/HA
• 00885554018660: TF ULTRA 2 UB AND NDLS 5.5MM PLLA/HA
• 00885554018639: TF ULTRA 2 UB AND NDLS 4.5MM PLLA/HA
• 00885554012903: TWINFIX AB 5.0 ULTRABRAID 5 PCK
• 03596010656209: TF ULTRA 2 UBRAID AND NDLS 5.5MM PK
• 03596010656193: TF ULTRA 2 UBRAID AND NDLS 6.5MM PK
• 03596010656186: TF ULTRA 2 UBRAID AND NDLS 4.5MM PK
• 03596010656179: TWINFIX ULTRA PK 6.5MM BLUE/WHTE & BLUE
• 03596010656162: TWINFIX ULTRA PK 5.5MM BLUE/WHTE & BLUE
• 03596010656155: TWINFIX ULTRA PK 4.5MM BLUE/WHTE & BLUE
• 03596010656148: TF ULTRA 2 UBRAID AND NDLS 6.5MM TI
• 03596010656124: TF ULTRA 2 UBRAID AND NDLS 4.5MMTI
• 03596010652324: TWINFIX ULTRA 6.5MM W/3 UB
• 03596010652300: TWINFIX ULTRA 6.5MM W/2 UB (BLK & BLUE)
• 03596010652294: TWINFIX ULTRA 6.5MM W/2 UB (WHT & BLUE)
• 03596010652287: TWINFIX ULTRA TI 4.5 W/2 UB (WH & BLUE)
• 03596010652270: TWINFIX ULTRA 5.5MM W/2 UB (BLK & BLUE)
• 03596010652263: TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE)
• 03596010652256: TWINFIX ULTRA 4.5MM W/2 UB (BLK &BLUE)
• 03596010647627: TWINFIX ULTRA PLLA/HA 6.5 W/3 UB
• 03596010647610: TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)
• 03596010647603: TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL
• 03596010647597: TWINFIX ULTRA PLLA/HA 5.5 W/3 UB
• 03596010647580: TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK
• 03596010647573: TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL
• 03596010647566: TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK
• 03596010647559: TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE
• 03596010647542: TWINFIX ULTRA PK 6.5MM W/ 2 UB-BL & BLK
• 03596010647535: TWINFIX ULTRA PK 5.5MM W/ 2 UB-BL &BLK
• 03596010647528: TWINFIX ULTRA PK 4.5MM W/2 UB-BL &BLK
• 03596010647504: TWINFIX ULTRA PK 6.5MM W/3 UB-WHT BL&BLK
• 03596010647498: TWINFIX ULTRA PK 6.5MM W/ 2 UB-WHT&BL
• 03596010647481: TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK
• 03596010647474: TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL
• 03596010647467: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL
• 03596010622259: TWINFIX PK FT 6.5 W/2 UB CO-BRAID
• 03596010622242: TWINFIX PK FT 5.5 W/2 UB CO-BR & AWL
• 03596010622235: TWINFIX PK FT 5.5 W/2 ULTRABRAID CO-BR
• 03596010604781: TWINFIX PK FT 6.5 W/3 ULTRABRAID & AWL
• 03596010604774: TWINFIX PK FT 6.5 W/2 ULTRABRAID & AWL
• 03596010604767: TWINFIX PK FT 6.5 ANCH W/3 ULTRABRAID
• 03596010604750: TWINFIX PK FT 6.5 ANCH W/2 ULTRABRAID
• 03596010604743: TWINFIX PK FT 5.5 W/3 ULTRABRAID & AWL
• 03596010604736: TWINFIX PK FT 5.5 W/2 ULTRABRAID & AWL
• 03596010604729: TWINFIX PK FT 5.5 ANCH W/3 ULTRABRAID
• 03596010502438: TWINFIX TI 3.5 STR ANCHR W/2 ULTRBRD S
• 03596010502421: TWINFIX TI 5.0 ANCH W/2 ULTRABRAID SU
• 03596010001818: TWINFIX PK FT 5.5 ANCH W/2 ULTRABRAID