Introducer Sheath

GUDID 20613994840312

SHEATH 3805-012 PEELAWAY INTRO D12 5PK

MEDTRONIC PS MEDICAL, INC.

Wire/ligature passer, reusable

• Primary Device ID: 20613994840312
• NIH Device Record Key: f61e4f2b-9068-42b9-9724-e6c8b5a352a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Introducer Sheath
• Version Model Number: 3805-012
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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: false
• Expiration Date: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994840318 [Unit of Use]
GS1	20613994840312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990333

FDA Product Code

• GWG: ENDOSCOPE, NEUROLOGICAL

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: 2018-07-24
• Device Publish Date: 2016-06-13

On-Brand Devices [Introducer Sheath]

• 20613994840336: SHEATH 3805-015 PEELAWAY INTRO D15 5PK
• 20613994840329: SHEATH 3805-014 PEELAWAY INTRO D14 5PK
• 20613994840312: SHEATH 3805-012 PEELAWAY INTRO D12 5PK