DYONICS / INCISOR 7205693

GUDID 23596010477891

INCISOR PLUS MINI IRRIGATING

Smith & Nephew, Inc.

Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use

• Primary Device ID: 23596010477891
• NIH Device Record Key: cc7e97c8-f85a-4b14-b4ec-b5738ddd26aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYONICS / INCISOR
• Version Model Number: 7205693
• Catalog Number: 7205693
• 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
• 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
• 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	03596010477897 [Primary]
GS1	23596010477891 [Package]; Contains: 03596010477897; Package: BX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970511

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-10-05

On-Brand Devices [DYONICS / INCISOR]

• 20885556708907: 4.5MM INCISOR PLUS ELITE PLATINUM CURVED BLADE
• 23596010654452: INCISOR PLUS ELITE POWER-MINI DISP 2.9
• 23596010651352: MTO BLADE INCISOR 4.0 DSPL /6
• 23596010620129: MTO BLADE 4.5 SHARP INCISR PLUS DSPL DYO
• 23596010560234: BURR ACROMIONIZER 4.0 LG SUCT WDO DSPL
• 23596010555919: CURVED LONG INCISOR PLUS ELITE BLADE
• 23596010555704: CURVED INCISOR PLUS ELITE BL 4.5MM
• 23596010555681: INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX
• 23596010553854: INCISOR PLUS ELITE LONG 4.5MM
• 23596010532620: INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW
• 23596010477891: INCISOR PLUS MINI IRRIGATING
• 23596010463047: BLADE MINI INCISOR 2.9MM DSPL 6/BX
• 23596010445791: INCISOR EP-1 4.5MM ORBIT (6)
• 23596010445760: BOXED INCISOR BL. 4.5MM CNCV(6)
• 23596010408383: INCISOR CONC CRV MINI IRRIG BL
• 23596010374923: 3.5MM INCISOR PLUS 8CM LENGTH
• 23596010252573: INCISOR CONCAVE CRV M.A.S.S.
• 23596010252320: INCISOR M.A.S.S. 3.5X8CM 6/BOX
• 23596010252238: INCISOR PLUS 5.5MM EP-1 DSPL BLADE
• 23596010251682: BOXED INCISOR PLUS BL (BX6)
• 23596010251675: INCISOR BLADE EP-1 LONG 4.5
• 23596010251606: BOXED INCISOR BLADE 4.5(6BX)
• 23596010251422: INCISOR 5.5MM EP-1 DSPL BLADE
• 23596010251415: INCISOR BLADE 4.5 DSPL EP-1(BX6)
• 23596010251408: INCISOR BLADE 3.5MM DSPL EP-1
• 23596010126096: INCISOR 3.5 DISP BOX/6 MINI BL