Navio PFSDV0016

GUDID 20885556628908

Navio Flat Markers

Smith & Nephew, Inc.

Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use Surgical optical-tracking spatial marker, single-use

• Primary Device ID: 20885556628908
• NIH Device Record Key: cf81833c-7084-4f84-b5bd-b2001dae6c33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navio
• Version Model Number: PFSDV0016
• Catalog Number: PFSDV0016
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 9
• 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
• 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	00885556628904 [Unit of Use]
GS1	20885556628908 [Primary]
GS1	30885556628905 [Package]; Package: BX [2 Units]; In Commercial Distribution
GS1	40885556628902 [Package]; Contains: 30885556628905; Package: CAS [10 Units]; In Commercial Distribution

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-03-22
• Device Publish Date: 2016-09-21

On-Brand Devices [Navio]

• 00885556693483: NAVIO TKA FMR STERILIZATION TRAY LID
• 00885556693476: NAVIO TKA FMR STERILIZATION TRAY BASE
• 00885556693469: NAVIO SMALL PARTS STERILIZATION CASE
• 20885556685321: NAVIO BONE PIN 3.5MM X 114MM
• 20885556685314: NAVIO BONE PIN 4.0MM X 152MM
• 00885556685136: NAVIO TKA RIGHT TIBIA CUT GUIDE MEDIUM
• 00885556685129: NAVIO TKA RIGHT TIBIA CUT GUIDE SMALL
• 00885556685112: NAVIO TKA LEFT TIBIA CUT GUIDE MEDIUM
• 00885556685105: NAVIO TKA LEFT TIBIA CUT GUIDE SMALL
• 00885556685099: NAVIO TKA FEMUR DISTAL CUT GUIDE LARGE
• 00885556685082: NAVIO TKA FEMUR DISTAL CUT GUIDE MEDIUM
• 00885556685075: NAVIO TKA FEMUR DISTAL CUT GUIDE SMALL
• 00885556685068: NAVIO TKA PLANE VISUALIZATION TOOL
• 00885556685051: NAVIO TKA FEMUR CUT ADAPTER
• 00885556684979: NAVIO TKA RIGHT TIBIA TWIN PEG CUT GUIDE
• 00885556684962: TIP GRIP
• 00885556684955: NAVIO HANDPIECE HANDLE
• 00885556684948: NAVIO TOTAL KNEE INSTRUMENT KIT
• 00885556684931: NAVIO TKA FMR TIBIA CUT GUIDE TRAY
• 00885556684924: NAVIO TKA FMR STERILIZATION UTILITY TRAY
• 00885556684917: NAVIO TKA LEFT TIBIA TWIN PEG CUT GUIDE
• 00885556684900: NAVIO TKA DRILL GUIDE GENESIS II - LEGION
• 00885556684894: NAVIO TKA FMR STERILIZATION CASE - UNPOPULATED
• 00885556684887: NAVIO TKA DRILL GUIDE - JOURNEY II
• 00885556684870: NAVIO TKA FEMUR STABILIZER LARGE
• 00885556684863: NAVIO TKA FEMUR STABILIZER MEDIUM
• 00885556684856: NAVIO TKA FEMUR STABILIZER SMALL
• 00885556653968: NAVIO TKA INSTRUMENT KIT
• 00885556649558: NAVIO TISSUE PROTECTOR
• 20885556648425: NAVIO HANDPIECE THUMBERSCREW
• 00885556631935: NAVIO INSTRUMENT KIT
• 40885556628902: Navio Flat Markers
• 00885556628805: Navio Long Attachment Refurbished
• 00885556628799: Navio Handpiece Refurbished
• 00885556628744: Navio Surgical System Refurbished US
• 00885556628737: Navio Bone Pin 4.0mm x 127mm
• 00885556628720: Navio Checkpoint Verification Pins
• 00885556628713: Navio Soft Tissue Protector
• 00885556628706: Navio 6mm Exposure Control Guard
• 00885556628690: Navio 5mm Exposure Control Guard
• 00885556628683: Navio 4mm Exposure Control Guard
• 00885556628676: Navio 3.5mm Exposure Control Guard
• 00885556628669: Navio 3mm Exposure Control Guard
• 00885556628652: Navio 2mm Exposure Control Guard
• 00885556628645: Navio Speed Control Guard
• 00885556628638: Navio Z Knee Retractor
• 00885556628621: Navio Fomon Rasp
• 00885556628614: Navio Bone Screw Driver
• 00885556628607: Navio Long Attachment
• 00885556628577: Navio Handpiece Tracker Array