XLR

GUDID 00887517387820

XLR Trial, 14x38x28 8° Detachable

Nuvasive, Inc.

Spinal implant trial Spinal implant trial

• Primary Device ID: 00887517387820
• NIH Device Record Key: 5e5d961b-62e3-41c2-884d-2af02b43b366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLR
• Version Model Number: 6901488
• 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	00887517387820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161230

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00887517387820]

Moist Heat or Steam Sterilization

[00887517387820]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-09-17

On-Brand Devices [XLR]

• 00887517391759: XLR Trial, 20x38x28 15° Detachable
• 00887517391742: XLR Trial, 18x38x28 15° Detachable
• 00887517391735: XLR Trial, 16x38x28 15° Detachable
• 00887517391728: XLR Trial, 14x38x28 15° Detachable
• 00887517391711: XLR Trial, 12x38x28 15° Detachable
• 00887517388629: XLR Trial, 20x38x28 8° Detachable
• 00887517388612: XLR Trial, 20x34x24 8° Detachable
• 00887517388261: XLR Trial, 18x38x28 8° Detachable
• 00887517388254: XLR Trial, 18x34x24 8° Detachable
• 00887517388247: XLR Trial, 16x38x28 8° Detachable
• 00887517388230: XLR Trial, 16x34x24 8° Detachable
• 00887517387820: XLR Trial, 14x38x28 8° Detachable
• 00887517387813: XLR Trial, 14x34x24 8° Detachable
• 00887517387806: XLR Trial, 12x38x28 8° Detachable
• 00887517387493: XLR Trial, 12x34x24 8° Detachable
• 00887517387486: XLR Trial, 10x38x28 8° Detachable
• 00887517387479: XLR Trial, 10x34x24 8° Detachable
• 00887517384638: XLR Distractor, Tang Bottom
• 00887517384348: XLR Rasp
• 00887517383570: XLR Tamp, Implant Oblique
• 00887517383563: XLR Tamp, Implant Straight
• 00887517383532: XLR Inserter, Implant
• 00887517405739: ALIF EnVoy Instrument Tray Base