MaXcess

GUDID 00887517189165

MaXcess Access Blade, 80mm Center

Nuvasive, Inc.

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 00887517189165
• NIH Device Record Key: 235df2fb-89c1-4a98-aa5d-21c28fae7838
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaXcess
• Version Model Number: 3213080
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517189165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112709

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

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

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

[00887517189165]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-11
• Device Publish Date: 2018-09-17

On-Brand Devices [MaXcess]

• 00887517528223: MaXcess MAS TLIF Retractor, Solid
• 00887517528216: MaXcess MAS TLIF Retractor, Flexible
• 00887517528209: MaXcess MAS TLIF Shim, Lateral Right
• 00887517527899: MaXcess MAS TLIF Shim, Lateral Left
• 00887517525215: Vertebral Distractor
• 00887517521019: MaXcess III Access Shim Caddy Set
• 00887517520838: MaXcess Micro Decompression Set
• 00887517520821: MaXcess Micro Access Set
• 00887517520777: MaXcess-C A-Arm Tray
• 00887517520753: MaXcess-C Tray
• 00887517520746: MaXcess MAS TLIF Multi-level Instruments
• 00887517520739: MAS TLIF Access Set
• 00887517520715: MaXcess MAS TLIF Set
• 00887517520647: MaXcess MAS PLIF Access System
• 00887517520609: MaXcess IV Articulating Arm Set
• 00887517520593: MaXcess II Articulating Arm Set
• 00887517518439: MaXcess Decompression Set
• 00887517517098: Beta Cervical MaXcess
• 00887517515889: ALPHA MaXcess MAS TLIF Lateral Addition
• 00887517515629: ALPHA MAS PLIF Access
• 00887517515605: Alpha MAS TLIF 2
• 00887517514219: MaXcess MAS TLIF Ball Driver, 1/8"
• 00887517514097: MaXcess MAS TLIF Blade, Medial Blade L
• 00887517514080: MaXcess MAS TLIF Blade, Medial Blade M
• 00887517514073: MaXcess MAS TLIF Blade, Medial Blade S
• 00887517514059: MaXcess MAS TLIF Medial Rack
• 00887517514028: MaXcess MAS TLIF Blade, 100mm Left C-C
• 00887517514011: MaXcess MAS TLIF Blade, 90mm Left C-C
• 00887517514004: MaXcess MAS TLIF Blade, 80mm Left C-C
• 00887517499592: MaXcess MAS TLIF Blade, 70mm Left C-C
• 00887517499585: MaXcess MAS TLIF Blade, 60mm Left C-C
• 00887517499578: MaXcess MAS TLIF Blade, 50mm Left C-C
• 00887517462572: MAS TLIF Shankdriver, Dismantlable
• 00887517462558: MAS TLIF Hex Lobe Tip, Shankdriver
• 00887517460998: MAS TLIF Thumbwheel, Shankdriver
• 00887517460981: MAS TLIF Body Assembly, Shankdriver
• 00887517431905: MaXcess 4 Inserter, Low Profile Shim
• 00887517345028: MaXcessMAS PLIF Access Driver, w/Splay
• 00887517324788: MAS TLIF Ambiblade, 70mm Alpha
• 00887517324740: MaXcess-C Blade, 19x50mm Blunt
• 00887517324733: MaXcess-C Blade, 19x30mm Blunt
• 00887517324726: MaXcess-C Blade, 19x70mm Serrated
• 00887517324719: MaXcess-C Blade, 19x60mm Serrated
• 00887517319746: MAS TLIF Ambiblade Shim, 120mm Left
• 00887517319739: MAS TLIF Ambiblade Shim, 120mm Right
• 00887517285690: MaXcess Light Cable, Reusable
• 00887517212351: MAS PLIF Blade, 120mm Right Wide
• 00887517212344: MAS PLIF Blade, 110mm Right Wide
• 00887517212337: MAS PLIF Blade, 100mm Right Wide
• 00887517212320: MAS PLIF Blade, 90mm Right Wide