MAGNUM OM-9138

GUDID 00817470001211

MAGNUM X PLUS PP MW BLACK COBRAID

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00817470001211
• NIH Device Record Key: ac8a5bc3-c633-47dd-8b1d-00601c0f4c17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGNUM
• Version Model Number: OM-9138
• Catalog Number: OM-9138
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470001211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081497

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: 6
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-09-21

On-Brand Devices [MAGNUM]

• 00817470010541: MAGNUM MP
• 00817470007183: MAGNUM M
• 00817470006254: MAGNUM X PLUS PP MW BLUE COBRAID
• 00817470006247: MAGNUM X PLUS PP MW WHITE
• 00817470006230: MAGNUM X PLUS MW BLUE COBRAID
• 00817470006223: MAGNUM X PLUS MW WHITE
• 00817470006216: MAGNUM X WITH INDEPENDENT TENSIONIN
• 00817470006063: MAGNUM PI UNDERCUT PUNCHREPLACEMENT PIEC
• 00817470006056: MAGNUM PI UNDERCUT PUNCH
• 00817470005998: MINIMAGNUM IMPLANT DRILL
• 00817470005981: MINIMAGNUM DRILLGUIDE AND PATHFIND
• 00817470005967: MAGNUM PUNCH (3.2MM)
• 00817470005950: MAGNUM DRILL GUIDE AND PATHFINDER
• 00817470005943: MGNUM DRILL (3.2MM) NON-STERIL
• 00817470005691: MAGNUM PI PLUS SMARTSTITCH MAGNUMWIRE (C
• 00817470005684: MAGNUM PI PLUS SMARTSTITCH MAGNUMWIRE (W
• 00817470005677: MAGNUM PI PLUS PP MAGNUMWIRE COBRAID
• 00817470005660: MAGNUM PI PLUS PP MAGNUMWIRE WHITE
• 00817470005653: MAGNUM PI IMPLANT
• 00817470005615: MINI MAGNUM PLUS MW BLUE COBRAID
• 00817470005608: MINI MAGNUM PLUS MW WHITE
• 00817470005592: MINIMAGNUM KNOTLESS IMPLANT PKG
• 00817470005585: MAGNUM 2 PLUS PP MW BLUE COBRAID
• 00817470005578: MAGNUM 2 PLUS S-CONNECTOR MAGNUMWIRE (WH
• 00817470005530: MAGNUM2 PLUS (BLUE COBRAID MW)
• 00817470005523: MAGNUM2 PLUS (WHITE MW)
• 00817470005486: MAGNUM 2 KNOTLESS IMPLANT
• 00817470005189: MAGNUM X PLUS MW BLACK COBRAID
• 00817470005165: MAGNUM PI PLUS (BLACK COBRAID MW)
• 00817470005158: MAGNUM 2 PLUS MW BLACK COBRAID
• 00817470001211: MAGNUM X PLUS PP MW BLACK COBRAID
• 00817470001129: MAGNUM 2 PLUS MW BLACK COBRAID
• 00817470001068: MINI PLUS WITH BLACK COBRAID CARTRIDGE