ROB30031

GUDID 20885556924307

BONE PINS 2.9MM X 110MM QTY 3

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 20885556924307
• NIH Device Record Key: c215e0bf-bd79-4395-8965-5c0b4921d16c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ROB30031
• Catalog Number: ROB30031
• Company DUNS: 045483575
• 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)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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556924303 [Primary]
GS1	20885556924307 [Package]; Contains: 00885556924303; Package: BX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252841

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-18
• Device Publish Date: 2026-03-10

Devices Manufactured by Smith & Nephew, Inc.

• 00885556919712 - Real Intelligence: 2026-03-18 REAL INTELLIGENCE CORI CONSOLE XT
• 00885556919729 - Real Intelligence: 2026-03-18 Real Intelligence Tablet XT
• 00885556919743 - Real Intelligence: 2026-03-18 Real Intelligence Console Cart Column XT
• 00885556919750 - Real Intelligence: 2026-03-18 Real Intelligence Console Cart Base XT
• 00885556919767 - Real Intelligence: 2026-03-18 Real Intelligence Camera Cart Column XT
• 00885556919774 - Real Intelligence: 2026-03-18 Real Intelligence Camera Cart Base XT
• 00885556924198 - Real Intelligence: 2026-03-18 RI LITE BALL JOINT TRACKER INSTRUMENTS
• 00885556924204 - Real Intelligence: 2026-03-18 RI Universal Tracker Clamp