Prestige LP Streamlined Instruments

GUDID 00643169752993

RAIL PUNCH 6975405 RAIL PUNCH 5MM

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00643169752993
• NIH Device Record Key: 88cb9da9-96f0-41fc-9dd5-88b795e903da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prestige LP Streamlined Instruments
• Version Model Number: 6975405
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter
• Width: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169752993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090029

FDA Product Code

• MJO: Prosthesis, intervertebral disc

Sterilization

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

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

[00643169752993]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-11

On-Brand Devices [Prestige LP Streamlined Instruments]

• 00643169753020: RAIL PUNCH 6975408 RAIL PUNCH 8MM
• 00643169753013: RAIL PUNCH 6975407 RAIL PUNCH 7MM
• 00643169753006: RAIL PUNCH 6975406 RAIL PUNCH 6MM
• 00643169752993: RAIL PUNCH 6975405 RAIL PUNCH 5MM
• 00643169752986: GUIDE 6975208 DRILL GUIDE 8MM
• 00643169752979: GUIDE 6975207 DRILL GUIDE 7MM
• 00643169752962: GUIDE 6975206 DRILL GUIDE 6MM
• 00643169752955: GUIDE 6975205 DRILL GUIDE 5MM
• 00643169752207: TRIAL 6975288 TRIAL 8X18MM
• 00643169752191: TRIAL 6975268 TRIAL 8X16MM
• 00643169752184: TRIAL 6975248 TRIAL 8X14MM
• 00643169752177: TRIAL 6975287 TRIAL 7X18MM
• 00643169752160: TRIAL 6975267 TRIAL 7X16MM
• 00643169752153: TRIAL 6975247 TRIAL 7X14MM
• 00643169752146: TRIAL 6975286 TRIAL 6X18MM
• 00643169752139: TRIAL 6975266 TRIAL 6X16MM
• 00643169752122: TRIAL 6975246 TRIAL 6X14MM
• 00643169752115: TRIAL 6975226 TRIAL 6X12MM
• 00643169752108: TRIAL 6975265 TRIAL 5X16MM
• 00643169752092: TRIAL 6975245 TRIAL 5X14MM
• 00643169752085: TRIAL 6975225 TRIAL 5X12MM