Saber .035 48010008N

GUDID 20705032081112

SABER .035 PTA Dilation Catheter 10mm x 80mm x 80cm

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032081112
• NIH Device Record Key: 7cbb747d-01c2-4dd3-8292-dac6508065db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saber .035
• Version Model Number: 48010008N
• Catalog Number: 48010008N
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• 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: false
• 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

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
• 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
• 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
• 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	20705032081112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210626

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

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: 2021-12-23
• Device Publish Date: 2021-12-15

On-Brand Devices [Saber .035]

• 20705032081204: SABER .035 PTA Dilation Catheter 9mm x 20mm x 135cm
• 20705032081198: SABER .035 PTA Dilation Catheter 12mm x 20mm x 135cm
• 20705032081174: SABER .035 PTA Dilation Catheter 9mm x 20mm x 80cm
• 20705032081167: SABER .035 PTA Dilation Catheter 12mm x 20mm x 80cm
• 20705032081143: SABER .035 PTA Dilation Catheter 9mm x 20mm x 40cm
• 20705032081136: SABER .035 PTA Dilation Catheter 12mm x 20mm x 40cm
• 20705032081112: SABER .035 PTA Dilation Catheter 10mm x 80mm x 80cm
• 20705032081099: SABER .035 PTA Dilation Catheter 8mm x 20mm x 135cm
• 20705032081082: SABER .035 PTA Dilation Catheter 10mm x 80mm x 40cm
• 20705032081051: SABER .035 PTA Dilation Catheter 10mm x 80mm x 135cm
• 20705032081020: SABER .035 PTA Dilation Catheter 8mm x 20mm x 80cm
• 20705032080993: SABER .035 PTA Dilation Catheter 8mm x 20mm x 40cm
• 20705032080979: SABER .035 PTA Dilation Catheter 7mm x 80mm x 40cm
• 20705032080962: SABER .035 PTA Dilation Catheter 7mm x 80mm x 80cm
• 20705032080955: SABER .035 PTA Dilation Catheter 7mm x 80mm x 135cm
• 20705032080948: SABER .035 PTA Dilation Catheter 9mm x 100mm x 80cm
• 20705032080917: SABER .035 PTA Dilation Catheter 9mm x 100mm x 40cm
• 20705032080825: SABER .035 PTA Dilation Catheter 9mm x 100mm x 135cm
• 20705032080801: SABER .035 PTA Dilation Catheter 8mm x 80mm x 135cm
• 20705032080788: SABER .035 PTA Dilation Catheter 8mm x 80mm x 40cm
• 20705032080764: SABER .035 PTA Dilation Catheter 8mm x 80mm x 80cm
• 20705032080733: SABER .035 PTA Dilation Catheter 7mm x 120mm x 135cm
• 20705032080702: SABER .035 PTA Dilation Catheter 7mm x 120mm x 80cm
• 20705032080689: SABER .035 PTA Dilation Catheter 9mm x 40mm x 40cm
• 20705032080672: SABER .035 PTA Dilation Catheter 12mm x 40mm x 40cm
• 20705032080641: SABER .035 PTA Dilation Catheter 9mm x 40mm x 135cm
• 20705032080634: SABER .035 PTA Dilation Catheter 12mm x 40mm x 135cm
• 20705032080627: SABER .035 PTA Dilation Catheter 10mm x 60mm x 40cm
• 20705032080603: SABER .035 PTA Dilation Catheter 8mm x 40mm x 40cm
• 20705032080597: SABER .035 PTA Dilation Catheter 10mm x 60mm x 135cm
• 20705032080573: SABER .035 PTA Dilation Catheter 8mm x 40mm x 135cm
• 20705032080535: SABER .035 PTA Dilation Catheter 10mm x 60mm x 80cm
• 20705032080504: SABER .035 PTA Dilation Catheter 12mm x 40mm x 80cm
• 20705032080481: SABER .035 PTA Dilation Catheter 7mm x 60mm x 135cm
• 20705032080474: SABER .035 PTA Dilation Catheter 7mm x 60mm x 40cm
• 20705032080450: SABER .035 PTA Dilation Catheter 7mm x 60mm x 80cm
• 20705032080443: SABER .035 PTA Dilation Catheter 7mm x 250mm x 135cm
• 20705032080436: SABER .035 PTA Dilation Catheter 8mm x 40mm x 80cm
• 20705032080429: SABER .035 PTA Dilation Catheter 8mm x 100mm x 40cm
• 20705032080405: SABER .035 PTA Dilation Catheter 8mm x 100mm x 135cm
• 20705032080399: SABER .035 PTA Dilation Catheter 9mm x 40mm x 80cm
• 20705032080375: SABER .035 PTA Dilation Catheter 8mm x 100mm x 80cm
• 20705032080320: SABER .035 PTA Dilation Catheter 7mm x 300mm x 135cm
• 20705032080313: SABER .035 PTA Dilation Catheter 8mm x 60mm x 135cm
• 20705032080290: SABER .035 PTA Dilation Catheter 6mm x 300mm x 80cm
• 20705032080245: SABER .035 PTA Dilation Catheter 6mm x 300mm x 135cm
• 20705032080238: SABER .035 PTA Dilation Catheter 10mm x 100mm x 80cm
• 20705032080214: SABER .035 PTA Dilation Catheter 8mm x 60mm x 40cm
• 20705032080207: SABER .035 PTA Dilation Catheter 10mm x 100mm x 135cm
• 20705032080191: SABER .035 PTA Dilation Catheter 8mm x 60mm x 80cm