SurVeil DCB

GUDID 00812339030333

SurVeil DCB 4.0mm x 40mm x 135cm

Surmodics, Inc.

Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated Peripheral angioplasty balloon catheter, drug-coated

• Primary Device ID: 00812339030333
• NIH Device Record Key: 48d52f02-4f77-4c67-8bdc-2d1380c62295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurVeil DCB
• Version Model Number: SRV03513504040
• Company DUNS: 098414659
• Company Name: Surmodics, Inc.
• 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: true
• 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 Dimensions

• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter
• Balloon Diameter: 4 Millimeter
• Balloon Length: 40 Millimeter
• Catheter Length: 135 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812339030333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210025

FDA Product Code

• ONU: Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-12
• Device Publish Date: 2023-10-04

On-Brand Devices [SurVeil DCB]

• 00812339030548: SurVeil DCB 7.0mm x 100mm x 135cm
• 00812339030531: SurVeil DCB 7.0mm x 80mm x 135cm
• 00812339030524: SurVeil DCB 7.0mm x 60mm x 135cm
• 00812339030517: SurVeil DCB 7.0mm x 40mm x 135cm
• 00812339030500: SurVeil DCB 6.0mm x 150mm x 135cm
• 00812339030494: SurVeil DCB 6.0mm x 120mm x 135cm
• 00812339030487: SurVeil DCB 6.0mm x 100mm x 135cm
• 00812339030470: SurVeil DCB 6.0mm x 80mm x 135cm
• 00812339030463: SurVeil DCB 6.0mm x 60mm x 135cm
• 00812339030456: SurVeil DCB 6.0mm x 40mm x 135cm
• 00812339030449: SurVeil DCB 5.0mm x 150mm x 135cm
• 00812339030432: SurVeil DCB 5.0mm x 120mm x 135cm
• 00812339030425: SurVeil DCB 5.0mm x 100mm x 135cm
• 00812339030418: SurVeil DCB 5.0mm x 80mm x 135cm
• 00812339030401: SurVeil DCB 5.0mm x 60mm x 135cm
• 00812339030395: SurVeil DCB 5.0mm x 40mm x 135cm
• 00812339030388: SurVeil DCB 4.0mm x 150mm x 135cm
• 00812339030371: SurVeil DCB 4.0mm x 120mm x 135cm
• 00812339030364: SurVeil DCB 4.0mm x 100mm x 135cm
• 00812339030357: SurVeil DCB 4.0mm x 80mm x 135cm
• 00812339030340: SurVeil DCB 4.0mm x 60mm x 135cm
• 00812339030333: SurVeil DCB 4.0mm x 40mm x 135cm