Standard Introducer IK51221

GUDID M991IK512212

8F Standard Introducer Kit

NORFOLK MEDICAL

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• Primary Device ID: M991IK512212
• NIH Device Record Key: a9bb3910-9ffc-41e2-9001-ae3bf636f8ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Introducer
• Version Model Number: Straight Wing Tearaway
• Catalog Number: IK51221
• Company DUNS: 013861471
• Company Name: NORFOLK MEDICAL
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com
• Phone: +1(847)674-7075
• Email: npheil@norfolkmedical.com

Device Dimensions

• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter
• Length: 12 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M991IK512211 [Primary]
HIBCC	M991IK512212 [Package]; Contains: M991IK512211; Package: Box [2 Units]; In Commercial Distribution

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

[M991IK512212]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2015-09-01

On-Brand Devices [Standard Introducer]

• M991IK712212: 10F Standard Introducer Kit
• M991IK512212: 8F Standard Introducer Kit
• M991IK312212: 6F Standard Introducer Kit