Neuroform Atlas SZAS4515

GUDID 07613252656227

WITHOUT TIP Stent System

Stryker Corporation

Bare-metal intracranial vascular stent

• Primary Device ID: 07613252656227
• NIH Device Record Key: 3b925a56-82db-4483-a015-e773a80d7290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuroform Atlas
• Version Model Number: M003SZAS45150
• Catalog Number: SZAS4515
• Company DUNS: 042405446
• Company Name: Stryker Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com

Device Dimensions

• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252656227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H020002

FDA Product Code

• NJE: intracranial neurovascular stent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-01-12

On-Brand Devices [Neuroform Atlas]

• 07613252656241: WITHOUT TIP Stent System
• 07613252656234: WITHOUT TIP Stent System
• 07613252656227: WITHOUT TIP Stent System
• 07613252656210: WITHOUT TIP Stent System
• 07613252656203: WITHOUT TIP Stent System
• 07613252656197: WITHOUT TIP Stent System
• 07613252656180: WITHOUT TIP Stent System
• 07613252656173: WITHOUT TIP Stent System
• 07613252656166: WITHOUT TIP Stent System
• 07613252656159: WITHOUT TIP Stent System
• 07613252656142: WITHOUT TIP Stent System
• 07613252656135: WITHOUT TIP Stent System
• 07613252656128: WITH TIP Stent System
• 07613252656111: WITH TIP Stent System
• 07613252656104: WITH TIP Stent System
• 07613252656098: WITH TIP Stent System
• 07613252656081: WITH TIP Stent System
• 07613252656074: WITH TIP Stent System
• 07613252656067: WITH TIP Stent System
• 07613252656050: WITH TIP Stent System
• 07613252656043: WITH TIP Stent System
• 07613252656029: WITH TIP Stent System
• 07613252656012: WITH TIP Stent System
• 07613252656005: WITH TIP Stent System
• 07613327382235: WITHOUT TIP Stent System
• 07613327382228: WITHOUT TIP Stent System
• 07613327382211: WITHOUT TIP Stent System
• 07613327382204: WITHOUT TIP Stent System
• 07613327382198: WITHOUT TIP Stent System
• 07613327382181: WITHOUT TIP Stent System
• 07613327382174: WITHOUT TIP Stent System
• 07613327382167: WITHOUT TIP Stent System
• 07613327382150: WITHOUT TIP Stent System
• 07613327382143: WITHOUT TIP Stent System
• 07613327382136: WITHOUT TIP Stent System
• 07613327382129: WITHOUT TIP Stent System