REAL INTELLIGENCE ROB10027S

GUDID 00885556780879

REAL INTELLIGENCE TABLET

Smith & Nephew, Inc.

Laptop/tablet computer

• Primary Device ID: 00885556780879
• NIH Device Record Key: ade1cb54-cdf7-445a-8e5d-020f2a32bcc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAL INTELLIGENCE
• Version Model Number: ROB10027S
• Catalog Number: ROB10027S
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556780879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193120

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-11
• Device Publish Date: 2020-05-01

On-Brand Devices [REAL INTELLIGENCE]

• 00885556760000: UNIVERSAL INSERT LID (C)
• 00885556759998: UNIVERSAL INSERT LID (B)
• 00885556759981: UNIVERAL INSERT LID (A)
• 00885556759974: UNIVERSAL BASE TRAY LID
• 00885556757604: REAL INTELLIGENCE SHIPPING INSERT (F)
• 00885556757598: REAL INTELLIGENCE SHIPPING INSERT (C)
• 00885556757581: REAL INTELLIGENCE SHIPPING INSERT (B)
• 00885556757574: REAL INTELLIGENCE SHIPPING INSERT (A)
• 00885556757567: Universal INSERT LID (F)
• 00885556757550: JOURNEY II UNI ROBOTICS FINISHING INSERT (F)
• 00885556757543: REAL INTELLIGENCE ROBOTICS PIN CADDY LID
• 00885556757536: REAL INTELLIGENCE ROBOTICS PIN CADDY
• 00885556757529: REAL INTELLIGENCE ROBOTICS INSTRUMENTS TRAY
• 00885556757512: REAL INTELLIGENCE 6 MM CYLINDRICAL BUR
• 00885556757505: REAL INTELLIGENCE 5 MM CYLINDRICAL BUR
• 00885556757499: REAL INTELLIGENCE 6 MM CHIP BREAKER BULLET BUR
• 00885556757482: REAL INTELLIGENCE 6 MM BULLET BUR
• 30885556757476: REAL INTELLIGENCE FLAT MARKERS
• 00885556757468: REAL INTELLIGENCE TUBING SET
• 00885556757451: REAL INTELLIGENCE TABLET
• 00885556757444: REAL INTELLIGENCE FOOT PEDAL
• 00885556757437: REAL INTELLIGENCE TRACKING CAMERA
• 00885556757420: Real Intelligence Cori
• 00885556757413: REAL INTELLIGENCE CHECKPOINT TOOL
• 00885556757406: REAL INTELLIGENCE DRILL GUIDE
• 00885556757390: REAL INTELLIGENCE TRACKER CLAMP
• 00885556757345: REAL INTELLIGENCE ROBOTIC DRILL ATTACHMENT
• 00885556756256: REAL INTELLIGENCE 24 IN. TOUCH SCREEN
• 00885556780879: REAL INTELLIGENCE TABLET
• 00885556780862: REAL INTELLIGENCE TRACKING CAMERA
• 00885556780855: REAL INTELLIGENCE CORI
• 00885556780848: REAL INTELLIGENCE 24 IN. TOUCH SCREEN
• 00885556774151: REAL INTELLIGENCE ROBOTICS CART BASE 220
• 00885556774144: REAL INTELLIGENCE ROBOTICS CART BASE 120
• 00885556772799: REAL INTELLIGENCE ROBOTICS INSTRUMENTS
• 00885556756249: REAL INTELLIGENCE ROBOTICS CART COLUMN
• 00885556775530: REAL INTELLIGENCE FLEX BASE
• 00885556775523: UNIVERSAL INSERT LID (I)
• 00885556775516: UNIVERSAL INSERT LID (H)
• 00885556775509: JOURNEY II XR TIBIA IMPACTOR INSERT (GG)
• 00885556775493: UNIVERSAL INSERT LID (J)
• 00885556775486: JOURNEY II XR TIBIA FINISHING INSERT (J)
• 00885556775479: JOURNEY II TKA RIGHT TRIAL BASE
• 00885556775462: JOURNEY II TKA LEFT TRIAL BASE
• 00885556775455: UNIVERSAL INSERT LID (G)
• 00885556775448: JOURNEY II UNI LATERAL ROBOTICS MODULE
• 00885556775431: JOURNEY II UNIVERSAL SPACER TRIAL INSERT (CC)
• 00885556775424: JOURNEY II XR POLY UPSLOPE TRIAL INSERT RIGHT (HH)
• 00885556775417: JOURNEY II XR POLY UPSLOPE TRIAL INSERT LEFT (HH)
• 00885556775400: JOURNEY II XR POLY TRIAL INSERT RIGHT (CC)