SafeSheath® II SS12

GUDID 30891492002303

Hemostatic Tear-away Introducer System with Infusion Side Port, 12F

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 30891492002303
• NIH Device Record Key: 8ad3b9cd-6d6e-4b2e-9644-0798507f3970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSheath® II
• Version Model Number: SS12
• Catalog Number: SS12
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 5
• 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
• 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

• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge

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
• 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	00891492002302 [Unit of Use]
GS1	30891492002303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122084

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2019-06-07
• Device Publish Date: 2017-11-27

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