Precept

GUDID 00887517349965

PRECEPT Dilator, Screw

Nuvasive, Inc.

Fascial tissue dilator, reusable

• Primary Device ID: 00887517349965
• NIH Device Record Key: 2287fa06-ac70-4315-abe0-01d95116fafb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precept
• Version Model Number: 8801205
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517349965 [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

[00887517349965]

Moist Heat or Steam Sterilization

[00887517349965]

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: 2016-09-24

On-Brand Devices [Precept]

• 00887517526533: Precept Extended Taps and Drivers Tray
• 00887517521705: Precept Extended Taps and Drivers Tray
• 00887517521699: Precept Extra Guide and Pile Driver Tray
• 00887517521682: Precept Extra Guide and bull Dozer Tray
• 00887517521644: Precept Reduction XT Set
• 00887517521637: PRECEPT Reduction Implant Set
• 00887517521606: Precept Modular XT Set
• 00887517521583: PRECEPT Modular Configuration
• 00887517521538: Precept MOD - Dismantlable
• 00887517521521: Precept 7.5 Adjunct Tray
• 00887517521071: Precept Open Top Guide Instrument Set
• 00887517515711: PRECEPT Core Clip Ring Implant Set ALPHA
• 00887517491541: PRECEPT Guide, Needle
• 00887517476739: PRECEPT Open Instrument Tray
• 00887517476722: PRECEPT Long Construct Tray
• 00887517476715: PRECEPT Core Instrument Tray 2
• 00887517476708: PRECEPT Core Instrument Tray 1
• 00887517476494: PRECEPT Core Implant Tray
• 00887517453259: PRECEPT Shankdriver, Mod Extended
• 00887517453204: PRECEPT Screwdriver, Reduction Extended
• 00887517451057: ALPHA PRECEPT Extra Guide Set
• 00887517450685: PRECEPT Screw, 6.5x60mm Polyaxial S.R.
• 00887517450678: PRECEPT Screw, 6.5x55mm Polyaxial
• 00887517450661: PRECEPT Screw, 6.5x50mm Polyaxial
• 00887517450654: PRECEPT Screw, 6.5x45mm Polyaxial
• 00887517450647: PRECEPT Screw, 6.5x40mm Polyaxial
• 00887517450630: PRECEPT Screw, 6.5x35mm Polyaxial
• 00887517450623: PRECEPT Screw, 6.5x30mm Polyaxial
• 00887517449795: PRECEPT Screw, 5.5x60mm Polyaxial S.R.
• 00887517449788: PRECEPT Screw, 5.5x55mm Polyaxial
• 00887517449771: PRECEPT Screw, 5.5x50mm Polyaxial
• 00887517449764: PRECEPT Screw, 5.5x45mm Polyaxial
• 00887517449757: PRECEPT Screw, 5.5x40mm Polyaxial
• 00887517449740: PRECEPT Screw, 5.5x35mm Polyaxial
• 00887517449733: PRECEPT Screw, 5.5x30mm Polyaxial
• 00887517449337: PRECEPT Screw, 4.5x60mm Polyaxial S.R.
• 00887517449320: PRECEPT Screw, 4.5x55mm Polyaxial S.R.
• 00887517449313: PRECEPT Screw, 4.5x50mm Polyaxial S.R.
• 00887517449306: PRECEPT Screw, 4.5x45mm Polyaxial
• 00887517449092: PRECEPT Screw, 4.5x40mm Polyaxial
• 00887517449085: PRECEPT Screw, 4.5x35mm Polyaxial
• 00887517449078: PRECEPT Screw, 4.5x30mm Polyaxial
• 00887517449061: PRECEPT Screw, 4.5x25mm Polyaxial
• 00887517431592: PRECEPT Screw, 10.5x120mm Fixed
• 00887517431585: PRECEPT Screw, 10.5x110mm Fixed
• 00887517431578: PRECEPT Screw, 10.5x100mm Fixed
• 00887517431561: PRECEPT Screw, 10.5x90mm Fixed
• 00887517431554: PRECEPT Screw, 10.5x80mm Fixed
• 00887517431547: PRECEPT Screw, 10.5x70mm Fixed
• 00887517431530: PRECEPT Screw, 10.5x60mm Fixed