Affix

GUDID 00887517497109

Affix III Base

Nuvasive, Inc.

Device sterilization/disinfection container, reusable

• Primary Device ID: 00887517497109
• NIH Device Record Key: ee4038c8-feed-4223-8cbf-98249f0d9b43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affix
• Version Model Number: 1660200
• 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	00887517497109 [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

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

[00887517497109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [Affix]

• 00887517497093: Affix III Cutter, Rod
• 00887517497086: Affix III Template, 55mm
• 00887517497079: Affix III Template, 45mm
• 00887517497062: Affix III Template, 35mm
• 00887517497055: Affix III Inserter, Alternate
• 00887517497048: Affix III Compressor, Auxiliary
• 00887517497031: Affix III Driver, Set Screw
• 00887517497024: Affix III Inserter-Compressor
• 00887517257772: Affix® III Plate, 55mm
• 00887517257758: Affix® III Plate, 45mm
• 00887517257734: Affix® III Plate, 35mm
• 00887517122629: Affix II S Bladed Plate Tamp
• 00887517063236: Affix II Template, 25mm Straight
• 00887517062727: Affix II Template, 55mm Clip-On
• 00887517062710: Affix II Template, 45mm Clip On
• 00887517062703: Affix II Template, 35mm Clip-On
• 00887517062390: Affix II Template, 55mm Straight
• 00887517062383: Affix II Template, 45mm Straight
• 00887517062376: Affix II Template, 35mm Straight
• 00887517062369: Affix II Plate, 55mm
• 00887517062352: Affix II Plate, 45mm
• 00887517062345: Affix II Plate, 35mm
• 00887517062338: Affix II Mini, 25mm
• 00887517059185: Affix II S Bladed Plate, 45mm
• 00887517059178: Affix II S Bladed Plate, 40mm
• 00887517059161: Affix II S Bladed Plate, 35mm
• 00887517058683: Affix Plate, 55mm Spinous Process
• 00887517058676: Affix Plate, 45mm Spinous Process
• 00887517063694: Affix II S Bladed Plate, 45mm
• 00887517063687: Affix II S Bladed Plate, 40mm
• 00887517063670: Affix II S Bladed Plate, 35mm
• 00887517790248: Affix III Post Cutter
• 00887517790224: Affix III Inserter, Alternate
• 00887517790200: Affix III Compressor, Auxiliary
• 00887517790187: Affix III Final Driver, NV-12
• 00887517790163: Affix III Holder, Post
• 00887517790149: Affix III Perforator
• 00887517790125: Affix III Handle, Torque
• 00887517790101: Affix III Inserter, Lock Plate
• 00887517790088: Affix III Unlock Tool
• 00887517790064: Affix III Inserter/Compressor
• 00887517790040: Affix III Plate, 55mm
• 00887517790026: Affix III Plate, 45mm
• 00887517790002: Affix III Plate, 35mm
• 00887517650504: Affix III Template, 50mm Offset
• 00887517645999: Affix III Template, 45mm Offset
• 00887517645982: Affix III Template, 40mm Offset
• 00887517645975: Affix III Template, 55mm
• 00887517645968: Affix III Template, 50mm
• 00887517645951: Affix III Template, 45mm