ENDOBUTTON 72200150

GUDID 03596010597298

ENDOBUTTON CL ULTRA 35MM

Smith & Nephew, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 03596010597298
• NIH Device Record Key: 874cac90-bd8c-4f3d-8229-3d8856196fce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOBUTTON
• Version Model Number: 72200150
• Catalog Number: 72200150
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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)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	03596010597298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980155

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: 2015-08-29

On-Brand Devices [ENDOBUTTON]

• 00885556600955: MTO GUAGE DEPTH ENDOBUTTON MARKED TO 150
• 00885556529423: 9NDOBUTTON FIXATION BUTTON 4MM X 18MM
• 00885556529416: ENDOBUTTON FIXATION BUTTON 4 X 16
• 00885554028546: ENDOBUTTON CL ULTRA 10MM
• 00885554026214: ENDOBUTTON DIRECT WITH SUTURES 10MM
• 00885554026207: ENDOBUTTON DIRECT WITH SUTURES 9MM
• 00885554026191: ENDOBUTTON DIRECT WITH SUTURES 8MM
• 00885554026184: ENDOBUTTON DIRECT WITH SUTURES 7MM
• 00885554026177: ENDOBUTTON DIRECT WITH SUTURES 6MM
• 00885554026160: ENDOBUTTON DIRECT WITH SUTURES 5MM
• 00885554021738: ENDOBUTTON CL BTB 15MM STERILE BX OF1
• 00885554021349: MTO ENDOBUTTON PROBE
• 00885554015614: MTO DEPTH PRB ENDOBUTTON W/ PIN PULLER
• 00885554015041: ENDOBUTTON DIRECT FIXATION DEVICE 10MM
• 00885554012293: ENDOBUTTON CL PAC LTX
• 00885554011746: ENDOBUTTON PAC LTX
• 00885554006650: MTO GUAGE DEPTH ENDOBUTTON 30MM TO 180MM
• 00885554001204: MTO CAN ENDOBUTTON DEPTH PROBE
• 03596010652898: MTO ENDOBUTTON TWINBRIDGE FIX DEVICE
• 03596010651556: ASSEMBLY ENDOBUTTON INDICATOR
• 03596010606624: RULER ENDOBUTTON DIRECT
• 03596010606617: HLDR ENDOBUTTON DIRECT FIXATION DEVICE
• 03596010597342: ENDOBUTTON CL ULTRA 60MM
• 03596010597335: ENDOBUTTON CL ULTRA 55MM
• 03596010597328: ENDOBUTTON CL ULTRA 50MM
• 03596010597311: ENDOBUTTON CL ULTRA 45MM
• 03596010597304: ENDOBUTTON CL ULTRA 40MM
• 03596010597298: ENDOBUTTON CL ULTRA 35MM
• 03596010597281: ENDOBUTTON CL ULTRA 30MM
• 03596010597274: ENDOBUTTON CL ULTRA 25MM
• 03596010597267: ENDOBUTTON CL ULTRA 20MM
• 03596010597250: ENDOBUTTON CL ULTRA 15MM
• 03596010592361: ENDOBUTTON DIRECT FIXATION DEVICE 9MM
• 03596010592026: ENDOBUTTON DIRECT FIXATION DEVICE 8MM
• 03596010592019: ENDOBUTTON DIRECT FIXATION DEVICE 7MM
• 03596010592002: ENDOBUTTON DIRECT FIXATION DEVICE 6MM
• 03596010591999: ENDOBUTTON DIRECT FIXATION DEVICE 5MM
• 03596010514189: ADJ KNOB ENDOBUTTON DEPTH GAUGE
• 03596010497048: ENDBUTN CL BTB STERILE 60MM BOX OF 1
• 03596010497031: ENDBUTN CL BTB STERILE 55MM BOX OF 1
• 03596010497024: ENDBUTN CL BTB STERILE 50MM BOX OF 1
• 03596010497017: ENDBUTN CL BTB STERILE 45MM BOX OF 1
• 03596010497000: ENDBUTN CL BTB STERILE 40MM BOX OF 1
• 03596010496997: ENDBUTN CL BTB STERILE 35MM BOX OF 1
• 03596010496980: ENDBTN CL BTB STERILE 30MM BOX OF ONE
• 03596010496973: ENDBUTN CL BTB STERILE 25MM BOX OF 1
• 03596010469731: ENDOBUTTON CL PAC LTX FREE
• 03596010411105: GAUGE DEPTH ENDO-BUTTON
• 03596010388292: ENDOBUTTON CL 30MM
• 03596010388285: ENDOBUTTON CL 25MM