ALARA Neuro Access Needle Kit

GUDID 00858406007365

ALARA Neuro Access Needle - Diamond Tip

SURGENTEC, LLC

Nerve-locating probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use

• Primary Device ID: 00858406007365
• NIH Device Record Key: c606cf91-f470-4701-91cf-795e517da2de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALARA Neuro Access Needle Kit
• Version Model Number: AAN-09-NSW
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00858406007365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190163

FDA Product Code

• PDQ: Neurosurgical Nerve Locator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-04
• Device Publish Date: 2019-08-27

On-Brand Devices [ALARA Neuro Access Needle Kit]

• 00858406007396: ALARA Neuro Access Needle Two Pack - Diamond Tip
• 00858406007389: ALARA Neuro Access Needle Two Pack - Bevel Tip
• 00858406007419: ALARA Neuro Access Needle Two Pack - Diamond & Bevel Tip
• 00858406007372: ALARA Neuro Access Needle - Bevel Tip
• 00858406007365: ALARA Neuro Access Needle - Diamond Tip
• 00858406007341: ALARA Neuro Access Needle Kit with Extension Handle- Bevel Tip
• 00858406007334: ALARA Neuro Access Needle Kit with Extension Handle- Diamond Tip
• 00858406007327: ALARA Neuro Access Needle Kit Two Pack - Bevel Tip
• 00858406007310: ALARA Neuro Access Needle Kit Two Pack - Diamond & Bevel Tip
• 00858406007303: ALARA Neuro Access Needle Kit Two Pack - Diamond Tip
• 00858406007297: ALARA Neuro Access Needle Kit - Bevel Tip
• 00858406007129: ALARA Neuro Access Needle Kit - Diamond Tip