Gradient

GUDID 00887517481115

Gradient Plus - Implant Tray

Nuvasive, Inc.

Device sterilization/disinfection container, reusable

• Primary Device ID: 00887517481115
• NIH Device Record Key: c6d02b81-f290-44a3-bd1e-b7c60ca88a0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gradient
• Version Model Number: 7441900
• 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	00887517481115 [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

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

Moist Heat or Steam Sterilization

[00887517481115]

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 [Gradient]

• 00887517518828: Gradient Plus Ins Set
• 00887517518811: Gradient Plus Imp Set
• 00887517518804: Gradient Plus Fixed DTS Guide Set
• 00887517488176: Gradient Plus-R, 22mm 1-Level
• 00887517487407: Gradient Hole Cover, Round
• 00887517487391: Gradient Hole Cover, Slot
• 00887517487322: Gradient Screw, 4.5x16mm Variable
• 00887517487315: Gradient Screw, 4.5x14mm
• 00887517487308: Gradient Screw, 4.5x12mm
• 00887517487292: Gradient Screw, 4.5x10mm
• 00887517487285: Gradient Screw, 4.3x20mm Variable
• 00887517487278: Gradient Screw, 4.3x19mm Variable
• 00887517487261: Gradient Screw, 4.3x18mm Variable
• 00887517487254: Gradient Screw, 4.3x17mm Variable
• 00887517487247: Gradient Screw, 4.0x16mm Variable
• 00887517487230: Gradient Screw, 4.0x14mm
• 00887517487223: Gradient Screw, 4.0x12mm
• 00887517487216: Gradient Screw, 4.0x10mm
• 00887517487209: Gradient Plate, 95mm 5-Level
• 00887517487193: Gradient Plate, 110mm 5-Level
• 00887517487186: Gradient Plate, 105mm 5-Level
• 00887517487179: Gradient Plate, 100mm 5-Level
• 00887517482150: Gradient Tack, Temporary
• 00887517482143: Gradient Screw, 4.5x16mm Fixed
• 00887517482136: Gradient Screw, 4.5x14mm Fixed
• 00887517482129: Gradient Screw, 4.5x12mm Fixed
• 00887517482112: Gradient Screw, 4.5x10mm Fixed
• 00887517482105: Gradient Screw, 4x20mm Fixed
• 00887517481993: Gradient Screw, 4x19mm Fixed
• 00887517481986: Gradient Screw, 4x18mm Fixed
• 00887517481979: Gradient Screw, 4x17mm Fixed
• 00887517481962: Gradient Screw, 4x16mm Fixed
• 00887517481955: Gradient Screw, 4x14mm Fixed
• 00887517481948: Gradient Screw, 4x12mm Fixed
• 00887517481931: Gradient Screw, 4x10mm Fixed
• 00887517481924: Gradient Plate, 95mm Fixed 5-Level
• 00887517481917: Gradient Plate, 110mm Fixed 5-Level
• 00887517481900: Gradient Plate, 105mm Fixed 5-Level
• 00887517481795: Gradient Plate, 100mm Fixed 5-Level
• 00887517481788: Gradient Plate, 90mm Fixed 4-Level
• 00887517481771: Gradient Plate, 86mm Fixed 4-Level
• 00887517481764: Gradient Plate, 82mm Fixed 4-Level
• 00887517481757: Gradient Plate, 78mm Fixed 4-Level
• 00887517481740: Gradient Plate, 74mm Fixed 4-Level
• 00887517481733: Gradient Plate, 70mm Fixed 4-Level
• 00887517481726: Gradient Plate, 68mm Fixed 4-Level
• 00887517481719: Gradient Plate, 68mm Fixed 3-Level
• 00887517481702: Gradient Plate, 66mm Fixed 3-Level
• 00887517481597: Gradient Plate, 64mm Fixed 3-Level
• 00887517481580: Gradient Plate, 62mm Fixed 3-Level