Ebony 0.035" PTA OTW Catheter

GUDID 06091403535736

Ebony 0.035" PTA OTW Catheter, 6.00 x 150mm/ Shaft length 80cm

NATEC MEDICAL LTD

Peripheral angioplasty balloon catheter, basic
Primary Device ID06091403535736
NIH Device Record Keye2abc2d6-ca9c-4320-b963-b11e19101904
Commercial Distribution StatusIn Commercial Distribution
Brand NameEbony 0.035" PTA OTW Catheter
Version Model NumberPA036_00-150US
Company DUNS565545733
Company NameNATEC MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com
Phone+2304663054
Emailinfo@natec-medical.com

Device Dimensions

Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter
Balloon Diameter6 Millimeter
Balloon Length150 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS106091403535736 [Primary]

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-07
Device Publish Date2021-06-29

On-Brand Devices [Ebony 0.035" PTA OTW Catheter]

06091403535743Ebony 0.035" PTA OTW Catheter, 6.00 x 200mm/ Shaft length 80cm
06091403535736Ebony 0.035" PTA OTW Catheter, 6.00 x 150mm/ Shaft length 80cm
06091403535729Ebony 0.035" PTA OTW Catheter, 6.00 x 120mm/ Shaft length 80cm
06091403535705Ebony 0.035" PTA OTW Catheter, 6.00 x 80mm/ Shaft length 80cm
06091403535682Ebony 0.035" PTA OTW Catheter, 6.00 x 40mm/ Shaft length 80cm
06091403535668Ebony 0.035" PTA OTW Catheter, 5.00 x 200mm/ Shaft length 80cm
06091403535651Ebony 0.035" PTA OTW Catheter, 5.00 x 150mm/ Shaft length 80cm
06091403535644Ebony 0.035" PTA OTW Catheter, 5.00 x 120mm/ Shaft length 80cm
06091403535620Ebony 0.035" PTA OTW Catheter, 5.00 x 80mm/ Shaft length 80cm
06091403535606Ebony 0.035" PTA OTW Catheter, 5.00 x 40mm/ Shaft length 80cm
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