SafeSheath® II 667475-300

GUDID 20802526532744

Hemostatic Tear-away Introducer System with Infusion Side Port, 11F

Oscor Inc.

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• Primary Device ID: 20802526532744
• NIH Device Record Key: 717c24ea-c04e-4889-855d-36209a102bed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSheath® II
• Version Model Number: 667475-300
• Catalog Number: 667475-300
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	00802526532733 [Unit of Use]
GS1	20802526532744 [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: 2017-11-30

On-Brand Devices [SafeSheath® II]

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• 30891492002426: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 30891492002389: Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
• 30891492002372: Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
• 30891492002365: Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
• 30891492002358: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 30891492002341: Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
• 30891492002334: Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
• 30891492002327: Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
• 30891492002310: Hemostatic Tear-away Introducer System with Infusion Side Port, 12.5F
• 30891492002303: Hemostatic Tear-away Introducer System with Infusion Side Port, 12F
• 30891492002297: Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
• 30891492002280: Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
• 30891492002273: Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
• 30891492002266: Hemostatic Tear-away Introducer System with Infusion Side Port, 9.5F
• 30891492002259: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 30891492002242: Hemostatic Tear-away Introducer System with Infusion Side Port, 8.5F
• 30891492002235: Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
• 30891492002228: Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
• 30891492002211: Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
• 30891492002204: Hemostatic Tear-away Introducer System with Infusion Side Port, 5F
• 20802526532744: Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
• 20802526532706: Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
• 20802526532683: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 20802526532645: Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
• 20802526532621: Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
• 20802526532584: Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
• 20802526532560: Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
• 20802526532546: Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
• 20802526532522: Hemostatic Tear-away Introducer System with Infusion Side Port, 9.5F
• 20802526532508: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 20802526532485: Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
• 20802526532461: Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
• 20802526532447: Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
• 00885672009892: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 00885672009885: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F