DYONICS / FULL RADIUS 7205688

GUDID 20885554009136

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

• Primary Device ID: 20885554009136
• NIH Device Record Key: 2be02f91-af0d-4f40-8902-093e7a779138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYONICS / FULL RADIUS
• Version Model Number: 7205688
• Catalog Number: 7205688
• 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
• 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	00885554009132 [Primary]
GS1	20885554009136 [Package]; Contains: 00885554009132; 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 / FULL RADIUS]

• 20885554011832: FULL RADIUS BLADE CONVEX EP-1
• 20885554009136: FULL RADIUS MINI IRRIGATING
• 23596010621683: FULL RADIUS 2.0 MAG-MINI DISP. BLA
• 23596010621652: FULL RADIUS 3.5 MAG-MINI DISP. BLA
• 23596010595779: BLADE 3.5 CURVED CONCAVE FULL RADIUS
• 23596010582731: BLADE 5.5 FULL RADIUS ELITE DISPOSABLE
• 23596010532606: DISPOSABLE BL 4.5MM CURVED FR ELITE (6)
• 23596010532590: BLADE 3.5MM ELITE FULL RADIUS
• 23596010494768: DISPOSABLE BL 4.5MM FR ELITE
• 23596010462781: MTO BLADE 5.5 FULL RADIUS 180MM LG.
• 23596010445784: FULL RADIIUS EP-1 4.5 ORBIT /6
• 23596010440239: FULL RADIUS BLADE 5.5MM SER 3000
• 23596010252313: FULL RADIUS M.A.S.S. (6/BOX)
• 23596010251699: FULL RADIUS BLADE EP-1 4.5 BX /6
• 23596010251668: FULL RADIUS BLADE EP-1 LONG
• 23596010251637: FULL RADIUS BLADE CONVEX EP-1
• 23596010251620: FULL RADIUS BL CONCAVE EP-1 (BX 3)
• 23596010251354: FULL RADIUS BLADE 5.5MM DSPL. EP-1
• 23596010251347: FULL RADIUS BL 4.5MM DSPL. EP-1
• 23596010251330: FULL RADIUS BLADE 3.5MM DISP
• 23596010115939: FULL RADIUS 2.9 DSP MINI BLD(6
• 23596010115908: FULL RADIUS 2.0 DSP MINI BLD(6
• 03596010000996: MTO BL MINI 3.5 CRV CNCV FR 8CM LG
• 23596010000020: BOXED F/R BLADE 4.5MM CURVED/6