LITe 48850400

GUDID 07613327359596

Y-Needle 400

Stryker Corporation

Bone access cannula

• Primary Device ID: 07613327359596
• NIH Device Record Key: f7a30c81-579f-4e6f-a9a5-d1d4229aa72b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LITe
• Version Model Number: DI_48850400
• Catalog Number: 48850400
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327359596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171807

FDA Product Code

• PDQ: Neurosurgical nerve locator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-05

On-Brand Devices [LITe]

• 07613327359619: Y-Needle 200
• 07613327359602: Funnel
• 07613327359596: Y-Needle 400
• 07613327359589: Y-Needle 300
• 07613327359572: Y-Needle 100
• 37613327343565: Y-Wire (pack of 4)
• 37613327343558: Y-Wire (pack of 4)
• 37613327343541: Y-Wire (pack of 2)
• 37613327343534: Y-Wire (pack of 2)
• 37613327343527: Y-Wire (pack of 2)
• 37613327343510: Y-Wire (pack of 4)
• 37613327343480: Y-Wire (pack of 4) ES2 Compatible
• 37613327343459: Y-Wire (pack of 4)
• 37613327343442: Y-Wire (pack of 2)
• 37613327343435: Y-Wire (pack of 2) ES2 Compatible