MULTIFIX OM-1300

GUDID 00817470003178

MULTIFIX P

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00817470003178
• NIH Device Record Key: 443f0145-015c-4272-9627-33981642c461
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTIFIX
• Version Model Number: OM-1300
• Catalog Number: OM-1300
• 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: true
• 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
• 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	00817470003178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120096

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, 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: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-11-13

On-Brand Devices [MULTIFIX]

• 00817470004496: 6.5MM MFS DOUBLE ROW CONVENIENCE KIT
• 00817470004465: 6.5MM MULTIFIX S PLUS W/PP MW BLACK COB
• 00817470004434: 6.5MM MULTIFIX S PLUS W/PP MW BLUE COBR
• 00817470004427: 6.5MM MULTIFIX S PLUS W/PP MW WHITE
• 00817470004410: 5.5MM MFS DOUBLE ROW CONVENIENCE KIT
• 00817470004403: 5.5MM MULTIFIX S PLUS W/PP MW BLACK COB
• 00817470004359: 5.5MM MULTIFIX S PLUS W/PP MW BLUE COBR
• 00817470003390: DOUBLE ROW CONVENIENCE KIT
• 00817470003383: MULTIFIX P PLUS MAGNUMWIRE LOOSE
• 00817470003369: MULTIFIX P PLUS W/PP MW BLACK COB
• 00817470003291: MULTIFIX P PLUS W/PP MGW BLUE COBRAID
• 00817470003284: MULTIFIX P PLUS W/PP MW WHITE
• 00817470003178: MULTIFIX P
• 00817470002997: 5.5MM MULTIFIX S PLUS W/PP MW WHITE
• 00817470002546: MULTIFIX S PEEK 6.5MM
• 00817470000580: MULTIFIX S PEEK 5.5MM
• 00885556614211: MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR
• 00885556614204: MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR