Amethyst HP PTA OTW 0.035" catheter

GUDID 06091403562862

Amethyst HP PTA OTW 0.035" catheter, 5.00 X 80 MM /shaft length 75 CM

NATEC MEDICAL LTD

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 06091403562862
• NIH Device Record Key: 4d8bd152-a995-46cb-bbd5-1dbe1e761941
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amethyst HP PTA OTW 0.035" catheter
• Version Model Number: PH0805_00-80S
• Company DUNS: 565545733
• Company Name: NATEC MEDICAL LTD
• 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

Customer Support Contacts

• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com
• Phone: +2304663054
• Email: info@natec-medical.com

Device Dimensions

• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 5 Millimeter
• Balloon Length: 80 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	06091403562862 [Primary]

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: 2026-02-06
• Device Publish Date: 2026-01-29

On-Brand Devices [Amethyst HP PTA OTW 0.035" catheter]

• 06091403547920: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 80 MM /shaft length 135 CM
• 06091403547913: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 60 MM /shaft length 135 CM
• 06091403547906: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 40 MM /shaft length 135 CM
• 06091403547890: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 20 MM /shaft length 135 CM
• 06091403547883: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 80 MM /shaft length 135 CM
• 06091403547876: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 60 MM /shaft length 135 CM
• 06091403547869: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 40 MM /shaft length 135 CM
• 06091403547852: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 20 MM /shaft length 135 CM
• 06091403547845: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 100 MM /shaft length 135 CM
• 06091403547838: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 80 MM /shaft length 135 CM
• 06091403547821: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 60 MM /shaft length 135 CM
• 06091403547814: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 40 MM /shaft length 135 CM
• 06091403547807: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 20 MM /shaft length 135 CM
• 06091403547791: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 100 MM /shaft length 135 CM
• 06091403547784: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 80 MM /shaft length 135 CM
• 06091403547777: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 60 MM /shaft length 135 CM
• 06091403547760: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 40 MM /shaft length 135 CM
• 06091403547753: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 20 MM /shaft length 135 CM
• 06091403547746: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 80 MM /shaft length 75 CM
• 06091403547739: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 60 MM /shaft length 75 CM
• 06091403547722: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 40 MM /shaft length 75 CM
• 06091403547715: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 20 MM /shaft length 75 CM
• 06091403547708: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 80 MM /shaft length 75 CM
• 06091403547692: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 60 MM /shaft length 75 CM
• 06091403547685: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 40 MM /shaft length 75 CM
• 06091403547678: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 20 MM /shaft length 75 CM
• 06091403547661: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 100 MM /shaft length 75 CM
• 06091403547654: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 80 MM /shaft length 75 CM
• 06091403547647: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 60 MM /shaft length 75 CM
• 06091403547630: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 40 MM /shaft length 75 CM
• 06091403547623: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 20 MM /shaft length 75 CM
• 06091403547616: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 100 MM /shaft length 75 CM
• 06091403547609: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 80 MM /shaft length 75 CM
• 06091403547593: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 60 MM /shaft length 75 CM
• 06091403547586: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 40 MM /shaft length 75 CM
• 06091403547579: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 20 MM /shaft length 75 CM
• 06091403547562: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 80 MM /shaft length 50 CM
• 06091403547555: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 60 MM /shaft length 50 CM
• 06091403547548: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 40 MM /shaft length 50 CM
• 06091403547531: Amethyst HP PTA OTW 0.035" catheter, 10.00 X 20 MM /shaft length 50 CM
• 06091403547524: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 80 MM /shaft length 50 CM
• 06091403547517: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 60 MM /shaft length 50 CM
• 06091403547500: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 40 MM /shaft length 50 CM
• 06091403547494: Amethyst HP PTA OTW 0.035" catheter, 9.00 X 20 MM /shaft length 50 CM
• 06091403547487: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 100 MM /shaft length 50 CM
• 06091403547470: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 80 MM /shaft length 50 CM
• 06091403547463: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 60 MM /shaft length 50 CM
• 06091403547456: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 40 MM /shaft length 50 CM
• 06091403547449: Amethyst HP PTA OTW 0.035" catheter, 8.00 X 20 MM /shaft length 50 CM
• 06091403547432: Amethyst HP PTA OTW 0.035" catheter, 7.00 X 100 MM /shaft length 50 CM