PCM

GUDID 00887517521095

PCM Implant Set

Nuvasive, Inc.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00887517521095
• NIH Device Record Key: dce3371b-cd95-41fd-bcdf-1d8850c3e773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCM
• Version Model Number: PCMIMP
• Company DUNS: 053950783
• Company Name: Nuvasive, 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(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517521095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143579

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

[00887517521095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-10
• Device Publish Date: 2016-09-23

On-Brand Devices [PCM]

• 00887517525178: Terraced Reamer General Instrument Set
• 00887517521118: PCM Instrument Set
• 00887517521095: PCM Implant Set
• 00887517084071: PCM Trial, 8.0 mm Cervical Disc, Large
• 00887517084064: PCM Trial, 7.2 mm Cervical Disc, Large
• 00887517084057: PCM Trial, 6.5mm Cervical Disc, Large
• 00887517084040: PCM Trial, 8.0 mm Cervical Disc, Medium
• 00887517084033: PCM Trial, 7.2 mm Cervical Disc, Medium
• 00887517084026: PCM Trial, 6.5mm Cervical Disc, Medium
• 00887517084019: PCM Trial, 8.0 mm Cervical Disc, Small
• 00887517084002: PCM Trial, 7.2 mm Cervical Disc, Small
• 00887517083593: PCM Trial, 6.5mm Cervical Disc, Small
• 00887517083579: PCM Driver, Final (US)
• 00887517083562: PCM Inserter
• 00887517083555: PCM Loading Block
• 00887517083166: PCM Driver, Caspar Pin (US)
• 00887517083159: PCM Guide, 12mm Distraction Screw (US)
• 00887517083142: PCM Guide, 10mm Distraction Screw (US)
• 00887517083135: PCM Spacer Wedge, 8.0mm (US)
• 00887517083128: PCM Spacer Wedge, 6.5mm (US)
• 00887517083111: PCM Cervical Disc Sterilization Tray Nipple Mat
• 00887517083104: PCM Cervical Disc Instrument Tray, Bottom
• 00887517082596: PCM Cervical Disc Instrument Tray, Middle
• 00887517082589: PCM Cervical Disc Instrument Tray, Top
• 00887517082572: PCM Cervical Disc Instrument Case Lid
• 00887517082565: PCM Cervical Disc Instrument Case Base
• 00887517081605: Artificial Vertebral Disc, 8.0 mm Large
• 00887517081193: Artificial Vertebral Disc, 7.2 mm Large
• 00887517081186: Artificial Vertebral Disc, 6.5 mm Large
• 00887517081179: Artificial Vertebral Disc, 8.0 mm Medium
• 00887517081162: Artificial Vertebral Disc, 7.2 mm Medium
• 00887517081155: Artificial Vertebral Disc, 6.5 mm Medium
• 00887517081148: Artificial Vertebral Disc, 8.0 mm Small
• 00887517081131: Artificial Vertebral Disc, 7.2 mm Small
• 00887517081124: Artificial Vertebral Disc, 6.5mm Small
• 00887517080752: PCM Kerrison, 8.0mm Rim Wedge
• 00887517080745: PCM Kerrison, 7.2mm Rim Wedge
• 00887517080738: PCM Kerrison, 6.5mm Rim Wedge
• 00887517080721: PCM Kerrison, 5.7mm Rim Wedge
• 00887517079046: PCM Guide, Burr Sterile Rim
• 00887517079039: PCM Kerrison, Rim
• 00887517079008: PCM Broach, 5.7/6.5 Medium Modular
• 00887517078599: PCM Broach, 5.7/6.5 Small Modular
• 00887517078551: PCM Handle, Modular
• 00887517078544: PCM Drill, Modular Flange
• 00887517078537: PCM Screwdriver, Fixation
• 00887517077349: PCM Driver, Final
• 00887517076502: PCM Guide, Spacer Wedge
• 00887517075994: PCM Guide, Spacer Wedge
• 00887517075987: PCM Guide, Distraction Screw