PiGalileo TKR 75009254

GUDID 07611996063165

PLUS PIGALILEO TKR PLATE 6 DEG LOW PLUS

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 07611996063165
• NIH Device Record Key: 0214d3be-ec06-46d4-a59f-69f145c96d65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PiGalileo TKR
• Version Model Number: 75009254
• Catalog Number: 75009254
• 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: true
• Serial Number: false
• 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
• 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	07611996063165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061362

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

[07611996063165]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-13

On-Brand Devices [PiGalileo TKR]

• 07611996063189: PLUS PIGALILEO TKR PLATE 3 DEG HIGH PLUS
• 07611996063172: PLUS PIGALILEO TKR PLATE 0 DEG HIGH PLUS
• 07611996063165: PLUS PIGALILEO TKR PLATE 6 DEG LOW PLUS
• 07611996063158: PLUS PIGALILEO TKR PLATE 3 DEG LOW PLUS
• 07611996063141: PLUS PIGALILEO TKR PLATE 0 DEG LOW PLUS
• 07611996063134: PLUS PIGALILEO TKR MEDIAL BRACKET LG
• 07611996063127: PLUS PIGALILEO TKR MEDIAL BRACKET SM
• 07611996063110: PLUS PIGALILEO TKR FEM CLAMP PLIERS TKR
• 07611996063103: PLUS PIGALILEO TKR FEM CLAMP TKR .SLIM.