D-RAD SMART PACK 74682422

GUDID 00885556395240

D-RAD TITANIUM 2.4MM X 22MM CORTEX SCREW T7 SELF-TAPPING

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00885556395240
• NIH Device Record Key: a455b5d2-e802-4726-a766-4c82f68652ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-RAD SMART PACK
• Version Model Number: 74682422
• Catalog Number: 74682422
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556395240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132296

FDA Product Code

• HRS: PLATE, 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: 2015-09-21

On-Brand Devices [D-RAD SMART PACK]

• 00885556582985: D-RAD SMART PACK PLATE HOLDER
• 00885556399644: D-RAD SCREW AND TEMPLATE TRAY LID
• 00885556396445: D-RAD TITANIUM 2.4MM X 24MM LOCKING SCREW T7 SELF-TAPPING
• 00885556396346: D-RAD TITANIUM 2.4MM X 22MM LOCKING SCREW T7 SELF-TAPPING
• 00885556396247: D-RAD TITANIUM 2.4MM X 20MM LOCKING SCREW T7 SELF-TAPPING
• 00885556396148: D-RAD TITANIUM 2.4MM X 18MM LOCKING SCREW T7 SELF-TAPPING
• 00885556396049: D-RAD TITANIUM 2.4MM X 16MM LOCKING SCREW T7 SELF-TAPPING
• 00885556395943: D-RAD TITANIUM 2.4MM X 14MM LOCKING SCREW T7 SELF-TAPPING
• 00885556395844: D-RAD TITANIUM 2.4MM X 12MM LOCKING SCREW T7 SELF-TAPPING
• 00885556395745: D-RAD TITANIUM 2.4MM X 10MM LOCKING SCREW T7 SELF-TAPPING
• 00885556395349: D-RAD TITANIUM 2.4MM X 24MM CORTEX SCREW T7 SELF-TAPPING
• 00885556395240: D-RAD TITANIUM 2.4MM X 22MM CORTEX SCREW T7 SELF-TAPPING
• 00885556395141: D-RAD TITANIUM 2.4MM X 20MM CORTEX SCREW T7 SELF-TAPPING
• 00885556395042: D-RAD TITANIUM 2.4MM X 18MM CORTEX SCREW T7 SELF-TAPPING
• 00885556394946: D-RAD TITANIUM 2.4MM X 16MM CORTEX SCREW T7 SELF-TAPPING
• 00885556394847: D-RAD TITANIUM 2.4MM X 14MM CORTEX SCREW T7 SELF-TAPPING
• 00885556394748: D-RAD TITANIUM 2.4MM X 12MM CORTEX SCREW T7 SELF-TAPPING
• 00885556394649: D-RAD TITANIUM 2.4MM X 10MM CORTEX SCREW T7 SELF-TAPPING
• 00885556394441: D-RAD TITANIUM 1.8MM X 24MM LOCKING PEG T7
• 00885556394397: D-RAD TITANIUM 1.8MM X 22MM LOCKING PEG T7
• 00885556394342: D-RAD TITANIUM 1.8MM X 20MM LOCKING PEG T7
• 00885556394298: D-RAD TITANIUM 1.8MM X 18MM LOCKING PEG T7
• 00885556394243: D-RAD TITANIUM 1.8MM X 16MM LOCKING PEG T7
• 00885556394199: D-RAD TITANIUM 1.8MM X 14MM LOCKING PEG T7
• 00885556394144: D-RAD TITANIUM 1.8MM X 12MM LOCKING PEG T7
• 00885556364598: D-RAD SMART PACK 4 HOLE RIGHT WIDE PLATE
• 00885556364543: D-RAD SMART PACK 4 HOLE RIGHT STANDARD PLATE
• 00885556364499: D-RAD SMART PACK 4 HOLE LEFT WIDE PLATE
• 00885556364444: D-RAD SMART PACK 4 HOLE LEFT STANDARD PLATE
• 00885556364390: D-RAD PLATE TEMPLATES RIGHT
• 00885556364345: D-RAD PLATE TEMPLATES LEFT
• 00885556336540: D-RAD SCREW AND TEMPLATE TRAY