SABERX .014 PTA Dilatation Catheter 47535150M

GUDID 20705032089873

PTA, RX, 3.5 x 150, 150cm

CORDIS CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 20705032089873
• NIH Device Record Key: ae9f332a-fd96-4363-bb4a-3ba678b06717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABERX .014 PTA Dilatation Catheter
• Version Model Number: 47535150M
• Catalog Number: 47535150M
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032089873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221832

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: 2023-07-13
• Device Publish Date: 2023-07-05

On-Brand Devices [SABERX .014 PTA Dilatation Catheter]

• 20705032090251: PTA, RX, 3.0 x 200, 150cm
• 20705032090244: PTA, RX, 3.0 x 200, 200cm
• 20705032090176: PTA, RX, 4.0 x 100, 90cm
• 20705032090152: PTA, RX, 3.5 x 40, 150cm
• 20705032090145: PTA, RX, 2.0 x 150, 200cm
• 20705032090138: PTA, RX, 3.5 x 40, 200cm
• 20705032090121: PTA, RX, 2.0 x 150, 150cm
• 20705032090107: PTA, RX, 2.0 x 150, 90cm
• 20705032090084: PTA, RX, 3.0 x 200, 90cm
• 20705032090053: PTA, RX, 4.0 x 100, 150cm
• 20705032090039: PTA, RX, 4.0 x 100, 200cm
• 20705032090022: PTA, RX, 3.5 x 40, 90cm
• 20705032089996: PTA, RX, 2.5 x 150, 90cm
• 20705032089989: PTA, RX, 3.5 x 300, 200cm
• 20705032089958: PTA, RX, 3.5 x 300, 150cm
• 20705032089941: PTA, RX, 1.25 x 15, 90cm
• 20705032089934: PTA, RX, 2.5 x 300, 90cm
• 20705032089927: PTA, RX, 2.5 x 150, 150cm
• 20705032089903: PTA, RX, 2.5 x 150, 200cm
• 20705032089897: PTA, RX, 5.0 x 80, 150cm
• 20705032089880: PTA, RX, 3.5 x 300, 90cm
• 20705032089873: PTA, RX, 3.5 x 150, 150cm
• 20705032089859: PTA, RX, 3.5 x 150, 200cm
• 20705032089842: PTA, RX, 1.25 x 15, 200cm
• 20705032089835: PTA, RX, 5.0 x 80, 200cm
• 20705032089828: PTA, RX, 1.5 x 20, 90cm
• 20705032089811: PTA, RX, 1.25 x 15, 150cm
• 20705032089804: PTA, RX, 2.5 x 300, 150cm
• 20705032089781: PTA, RX, 2.5 x 300, 200cm
• 20705032089750: PTA, RX, 5.0 x 80, 90cm
• 20705032089743: PTA, RX, 1.5 x 20, 150cm
• 20705032089736: PTA, RX, 1.5 x 20, 200cm
• 20705032089729: PTA, RX, 3.5 x 150, 90cm
• 20705032089712: PTA, RX, 2.5 x 20, 90cm
• 20705032089705: PTA, RX, 2.5 x 250, 90cm
• 20705032089699: PTA, RX, 5.0 x 120, 200cm
• 20705032089682: PTA, RX, 5.0 x 120, 150cm
• 20705032089675: PTA, RX, 2.5 x 20, 200cm
• 20705032089668: PTA, RX, 2.5 x 250, 150cm
• 20705032089651: PTA, RX, 2.5 x 250, 200cm
• 20705032089644: PTA, RX, 2.5 x 20, 150cm
• 20705032089613: PTA, RX, 5.0 x 120, 90cm
• 20705032089590: PTA, RX, 6.0 x 80, 90cm
• 20705032089583: PTA, RX, 6.0 x 80, 150cm
• 20705032089576: PTA, RX, 6.0 x 80, 200cm
• 20705032089552: PTA, RX, 6.0 x 120, 200cm
• 20705032089545: PTA, RX, 6.0 x 120, 150cm
• 20705032089538: PTA, RX, 2.0 x 20, 150cm
• 20705032089521: PTA, RX, 2.0 x 250, 200cm
• 20705032089514: PTA, RX, 2.0 x 20, 200cm