Transseptal Introducer TSIL1881

GUDID 30858769006303

8F x 81cm Transseptal Introducer Set L1 Curve

PPMDM

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• Primary Device ID: 30858769006303
• NIH Device Record Key: 47442fca-7339-4ac9-8afd-44f5f4839554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transseptal Introducer
• Version Model Number: TSIL1881
• Catalog Number: TSIL1881
• Company DUNS: 081047841
• Company Name: PPMDM
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858769006302 [Primary]
GS1	30858769006303 [Package]; Contains: 00858769006302; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181031

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: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-11-09

On-Brand Devices [Transseptal Introducer]

• 30858769006341: 8.5F x 81cm Transseptal Introducer Set L1 Curve
• 30858769006334: 8.5F x 81cm Transseptal Introducer Set L0 Curve
• 30858769006327: 8.5F x 63cm Transseptal Introducer Set L1 Curve
• 30858769006310: 8.5F x 63cm Transseptal Introducer Set L0 Curve
• 30858769006303: 8F x 81cm Transseptal Introducer Set L1 Curve
• 30858769006297: 8F x 81cm Transseptal Introducer Set L0 Curve
• 30858769006280: 8F x 63cm Transseptal Introducer Set L1 Curve
• 30858769006273: 8F x 63cm Transseptal Introducer Set L0 Curve