SafeSept® NF Transseptal Guidewire Needle Free SSNF

GUDID 00891492002401

Transseptal Guidewire Needle Free

Oscor Inc.

Cardiac transseptal needle, single-use

• Primary Device ID: 00891492002401
• NIH Device Record Key: d0dc2e44-128a-41d4-b641-cc8cd91b1c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSept® NF Transseptal Guidewire Needle Free
• Version Model Number: SSNF
• Catalog Number: SSNF
• Company DUNS: 101835833
• Company Name: Oscor 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: 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

Customer Support Contacts

• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.0315 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00891492002401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130843

FDA Product Code

• DRC: Trocar

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: 2020-08-20
• Device Publish Date: 2017-11-27

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