BIORCI 7207560Z

GUDID 00885556608869

MTO BIORCI SCRW 8MMX25MM YLW/

Smith & Nephew, Inc.

Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw

• Primary Device ID: 00885556608869
• NIH Device Record Key: 3435b72f-fd26-44cf-9bc9-753ba7ab7c7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIORCI
• Version Model Number: 7207560Z
• Catalog Number: 7207560Z
• 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)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
• 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
• 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	00885556608869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992396

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-22

On-Brand Devices [BIORCI]

• 00885556608937: MTO BIORCI SCRW 10MMX35MM YLW/
• 00885556608920: MTO BIORCI SCRW 10MMX30MM YLW/
• 00885556608913: MTO BIORCI SCRW 9MMX35MM YLW/
• 00885556608906: MTO BIORCI SCRW 9MMX30MM YLW/
• 00885556608890: MTO BIORCI SCRW 9MMX25MM YLW/
• 00885556608883: MTO BIORCI SCRW 8MMX35MM YLW/
• 00885556608876: MTO BIORCI SCRW 8MMX30MM YLW/
• 00885556608869: MTO BIORCI SCRW 8MMX25MM YLW/
• 00885556608852: MTO BIORCI SCRW 7MM8MM HDX30
• 00885556608845: MTO BIORCI SCRW 7MM8MM HDX25
• 00885556608838: MTO BIORCI SCRW 7MM7MM HDX25
• 00885556603413: MTO BIORCI DRIVER W/GRAD MARKS TO 60MM
• 00885556602225: SOD DRVR BIORCI NON-CANN W/HDSN ADPTR
• 00885556601471: SOD TAP BIORCI 10MM W/THINNER
• 00885556601464: SOD TAP BIORCI 9MM W/THINNER
• 00885556601457: SOD TAP BIORCI 8MM W/THINNER
• 00885556601440: SOD TAP BIORCI 7MM W/THINNER
• 00885556570012: REFURB STARTER THREADED SCREW 8MM
• 00885556569771: REFURBTAPBIORCI10MM
• 00885556569764: REFURBTAPBIORCI9MM
• 00885556569757: REFURB TAP BIORCI 8MM
• 00885556569740: REFURB BIORCI 7MM
• 00885556569559: MTO DRIVER BIORCI W/HUDSON ADAPTOR
• 00885554010510: MTO TAP BIORCI 10MM W/HUDSON ADAPTOR
• 00885554010152: MTO TAP BIORCI 9MM W/HUDSON ADAPTOR
• 00885554009835: MTO TAP BIORCI 8MM W/HUDSON ADAPTOR
• 00885554009569: MTO TAP BIORCI 7MM W/HUDSON ADAPTOR
• 00885554007053: MTO DRVR BIORCI W/HDSN ADPTR EX 3 IN
• 00885554001525: MTO DRIVER BIORCI SCR HUDSON ADAP W/SET
• 03596010588975: MTO TAP 7MM BIORCI REVERSE THREAD
• 03596010525116: MTO BIORCI FLEXIBLE SCREW DRIVER
• 03596010485618: BIORCI SCRW 12MM X 35 STRL
• 03596010485601: BIORCI SCRW 11MM X 35MM STRL
• 03596010485595: BIORCI SCREW 11MMX30MM STRL BX 1
• 03596010485588: BIORCI SCRW 10MM X 25MM RVRS
• 03596010485564: BIORCI SCRW 9MM X 25MM REV
• 03596010485557: BIORCI SCRW 9MM X 20MM STRL
• 03596010485540: BIORCI SCRW 8MM X 20MM STRL
• 03596010473189: MTO DRIVER BIORCI W/HUDSON ADAPTOR
• 03596010473172: STARTER THREADED SCREW 8MM
• 03596010473165: STARTER THREADED SCREW 7MM
• 03596010460189: SCR BIORCI-HA 11X30 STERILE
• 03596010460110: SCR BIORCI-HA 10X25 R THR STER
• 03596010460103: SCR BIORCI-HA 9X25 R THR STERILE
• 03596010460097: SCR BIORCI-HA 8X25 R THD STERILE
• 03596010460073: SCR BIORCI-HA 12X35 STERILE
• 03596010460066: SCR BIORCI-HA 11X35 STERILE
• 03596010460059: SCR BIORCI-HA 10X35 STERILE
• 03596010460042: SCR BIORCI-HA 10X30 STERILE
• 03596010460035: SCR BIORCI-HA 10X25 STERILE