FDA.reportPublic FDA data

"USE® 0.014"" PTA RX Catheter"

Primary DI
06091403501618
Brand
"USE® 0.014"" PTA RX Catheter"
Company
NATEC MEDICAL LTD
Model
USE142_50-200RX
Device description
"USE® 0.014"" PTA RX Catheter, 2.50x200mm /Shaft length 150cm"
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06091403501618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06091403501618060914035016186091403501618

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Millimeter
Outer Diameter2.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00keep dry and Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+2304663054info@natec-medical.com

Regulatory Flags#

DUNS number
565545733
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06091403562626"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-40S2026-01-29
06091403562633"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-60S2026-01-29
06091403562640"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-80S2026-01-29
06091403562657"Amethyst HP PTA OTW 0.035"" catheter"PJ0804_00-100S2026-01-29
06091403562664"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-20S2026-01-29
06091403562671"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-40S2026-01-29
06091403562688"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-60S2026-01-29
06091403562695"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-80S2026-01-29
06091403562701"Amethyst HP PTA OTW 0.035"" catheter"PJ0805_00-100S2026-01-29
06091403562718"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-20S2026-01-29
06091403562725"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-40S2026-01-29
06091403562732"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-60S2026-01-29
06091403562749"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-80S2026-01-29
06091403562756"Amethyst HP PTA OTW 0.035"" catheter"PJ0806_00-100S2026-01-29
06091403562763"Amethyst HP PTA OTW 0.035"" catheter"PJ0812_00-20S2026-01-29
06091403562770"Amethyst HP PTA OTW 0.035"" catheter"PJ0812_00-40S2026-01-29
06091403562787"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-20S2026-01-29
06091403562794"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-40S2026-01-29
06091403562800"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-60S2026-01-29
06091403562817"Amethyst HP PTA OTW 0.035"" catheter"PH0804_00-80S2026-01-29

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