D-RAD 71158041

GUDID 00885556630631

D-RAD VOLAR PLATE 10H LEFT STANDARD TITANIUM

Smith & Nephew, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00885556630631
• NIH Device Record Key: 2ec61516-9704-454d-b5a3-93d98428783d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-RAD
• Version Model Number: 71158041
• Catalog Number: 71158041
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556630631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161665

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: 2016-11-29

On-Brand Devices [D-RAD]

• 00885556631768: D-RAD PLATE BENDING IRONS
• 00885556631690: D-RAD 1.8MM FIXED ANGLE AND VARIABLE ANGLE DRILL GUIDE
• 00885556631355: D-RAD VOLAR GUIDE BLOCK 5 HOLE RIGHT WIDE
• 00885556631348: D-RAD VOLAR GUIDE BLOCK 5 HOLE AND 10 HOLE RIGHT STANDARD
• 00885556631331: D-RAD VOLAR GUIDE BLOCK 5 HOLE LEFT WIDE
• 00885556631324: D-RAD VOLAR GUIDE BLOCK 5 HOLE AND 10 HOLE LEFT STANDARD
• 00885556631317: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE RIGHT WIDE
• 00885556631300: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE RIGHT STANDARD
• 00885556631294: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE LEFT WIDE
• 00885556631287: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE LEFT STANDARD
• 00885556630648: D-RAD VOLAR PLATE 10H RIGHT STANDARD TITANIUM
• 00885556630631: D-RAD VOLAR PLATE 10H LEFT STANDARD TITANIUM
• 00885556630624: D-RAD VOLAR PLATE 5H RIGHT WIDE TITANIUM
• 00885556630617: D-RAD VOLAR PLATE 5H RIGHT STANDARD TITANIUM
• 00885556630600: D-RAD VOLAR PLATE 5H LEFT WIDE TITANIUM
• 00885556630594: D-RAD VOLAR PLATE 5H LEFT STANDARD TITANIUM
• 00885556630587: D-RAD VOLAR PLATE 4H RIGHT WIDE TITANIUM
• 00885556630570: D-RAD VOLAR PLATE 4H RIGHT STANDARD TITANIUM
• 00885556630563: D-RAD VOLAR PLATE 4H LEFT WIDE TITANIUM
• 00885556630556: D-RAD VOLAR PLATE 4H LEFT STANDARD TITANIUM
• 00885556630549: D-RAD VOLAR PLATE 3H RIGHT WIDE TITANIUM
• 00885556630532: D-RAD VOLAR PLATE 3H RIGHT STANDARD TITANIUM
• 00885556630525: D-RAD VOLAR PLATE 3H LEFT WIDE TITANIUM
• 00885556630518: D-RAD VOLAR PLATE 3H LEFT STANDARD TITANIUM