Ebony HP PTA OTW 0.035" Catheter

GUDID 06091403542499

Ebony HP PTA OTW 0.035" Catheter, 10.00 X 40 MM /Shaft Length 135 CM

NATEC MEDICAL LTD

Peripheral angioplasty balloon catheter, basic
Primary Device ID06091403542499
NIH Device Record Key0f38e8aa-41a2-4947-b087-2710ace83f3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEbony HP PTA OTW 0.035" Catheter
Version Model NumberPG0710_00-40S
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

Device Dimensions

Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter
Balloon Diameter10 Millimeter
Balloon Length40 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS106091403542499 [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 Date2022-08-10
Device Publish Date2022-08-02

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

06091403547388Ebony HP PTA OTW 0.035" Catheter, 12.00 X 80 MM /Shaft Length 40 CM
06091403547371Ebony HP PTA OTW 0.035" Catheter, 12.00 X 60 MM /Shaft Length 40 CM
06091403547364Ebony HP PTA OTW 0.035" Catheter, 12.00 X 40 MM /Shaft Length 40 CM
06091403547357Ebony HP PTA OTW 0.035" Catheter, 12.00 X 20 MM /Shaft Length 40 CM
06091403547340Ebony HP PTA OTW 0.035" Catheter, 10.00 X 80 MM /Shaft Length 40 CM
06091403547333Ebony HP PTA OTW 0.035" Catheter, 10.00 X 60 MM /Shaft Length 40 CM
06091403547326Ebony HP PTA OTW 0.035" Catheter, 10.00 X 40 MM /Shaft Length 40 CM
06091403547319Ebony HP PTA OTW 0.035" Catheter, 10.00 X 20 MM /Shaft Length 40 CM
06091403547302Ebony HP PTA OTW 0.035" Catheter, 9.00 X 80 MM /Shaft Length 40 CM
06091403547296Ebony HP PTA OTW 0.035" Catheter, 9.00 X 60 MM /Shaft Length 40 CM
06091403547289Ebony HP PTA OTW 0.035" Catheter, 9.00 X 40 MM /Shaft Length 40 CM
06091403547272Ebony HP PTA OTW 0.035" Catheter, 9.00 X 20 MM /Shaft Length 40 CM
06091403547234Ebony HP PTA OTW 0.035" Catheter, 8.0 X 100 MM /Shaft Length 40 CM
06091403547227Ebony HP PTA OTW 0.035" Catheter, 8.00 X 80 MM /Shaft Length 40 CM
06091403547210Ebony HP PTA OTW 0.035" Catheter, 8.00 X 60 MM /Shaft Length 40 CM
06091403547203Ebony HP PTA OTW 0.035" Catheter, 8.00 X 40 MM /Shaft Length 40 CM
06091403547197Ebony HP PTA OTW 0.035" Catheter, 8.00 X 20 MM /Shaft Length 40 CM
06091403547159Ebony HP PTA OTW 0.035" Catheter, 7.00 X 100 MM /Shaft Length 40 CM
06091403547142Ebony HP PTA OTW 0.035" Catheter, 7.00 X 80 MM /Shaft Length 40 CM
06091403547135Ebony HP PTA OTW 0.035" Catheter, 7.00 X 60 MM /Shaft Length40 CM
06091403547128Ebony HP PTA OTW 0.035" Catheter, 7.00 X 40 MM /Shaft Length40 CM
06091403547111Ebony HP PTA OTW 0.035" Catheter, 7.00 X 20 MM /Shaft Length 40 CM
06091403547081Ebony HP PTA OTW 0.035" Catheter, 6.0 X 120 MM /Shaft Length 40 CM
06091403547074Ebony HP PTA OTW 0.035" Catheter, 6.0 X 100 MM /Shaft Length 40 CM
06091403547067Ebony HP PTA OTW 0.035" Catheter, 6.00 X 80 MM /Shaft Length40 CM
06091403547050Ebony HP PTA OTW 0.035" Catheter, 6.00 X 60 MM /Shaft Length 40 CM
06091403547043Ebony HP PTA OTW 0.035" Catheter, 6.00 X 40 MM /Shaft Length 40 CM
06091403547036Ebony HP PTA OTW 0.035" Catheter, 6.00 X 20 MM /Shaft Length 40 CM
06091403547005Ebony HP PTA OTW 0.035" Catheter, 5.00 X 120 MM /Shaft Length 40 CM
06091403546992Ebony HP PTA OTW 0.035" Catheter, 5.00 X 100 MM /Shaft Length 40 CM
06091403546985Ebony HP PTA OTW 0.035" Catheter, 5.00 X 80 MM /Shaft Length 40 CM
06091403546978Ebony HP PTA OTW 0.035" Catheter, 5.00 X 60 MM /Shaft Length 40 CM
06091403546961Ebony HP PTA OTW 0.035" Catheter, 5.00 X 40 MM /Shaft Length 40 CM
06091403546954Ebony HP PTA OTW 0.035" Catheter, 5.00 X 20 MM /Shaft Length 40 CM
06091403546916Ebony HP PTA OTW 0.035" Catheter, 4.00 X 100 MM /Shaft Length 40 CM
06091403546909Ebony HP PTA OTW 0.035" Catheter, 4.00 X 80 MM /Shaft Length 40 CM
06091403546893Ebony HP PTA OTW 0.035" Catheter, 4.00 X 60 MM /Shaft Length 40 CM
06091403546886Ebony HP PTA OTW 0.035" Catheter, 4.00 X 40 MM /Shaft Length 40 CM
06091403546879Ebony HP PTA OTW 0.035" Catheter, 4.00 X 20 MM /Shaft Length 40 CM
06091403546831Ebony HP PTA OTW 0.035" Catheter, 3.00 X 100 MM /Shaft Length 40 CM
06091403546824Ebony HP PTA OTW 0.035" Catheter, 3.00 X 80 MM /Shaft Length 40 CM
06091403546817Ebony HP PTA OTW 0.035" Catheter, 3.00 X 60 MM /Shaft Length 40 CM
06091403546800Ebony HP PTA OTW 0.035" Catheter, 3.00 X 40 MM /Shaft Length 40 CM
06091403546794Ebony HP PTA OTW 0.035" Catheter, 3.00 X 20 MM /Shaft Length 40 CM
06091403543151Ebony HP PTA OTW 0.035" Catheter, 12.00 X 80 MM /Shaft Length 75 CM
06091403543144Ebony HP PTA OTW 0.035" Catheter, 12.00 X 60 MM /Shaft Length 75 CM
06091403543137Ebony HP PTA OTW 0.035" Catheter, 12.00 X 40 MM /Shaft Length 75 CM
06091403543120Ebony HP PTA OTW 0.035" Catheter, 12.00 X 20 MM /Shaft Length 75 CM
06091403543113Ebony HP PTA OTW 0.035" Catheter, 10.00 X 80 MM /Shaft Length 75 CM
06091403543106Ebony HP PTA OTW 0.035" Catheter, 10.00 X 60 MM /Shaft Length 75 CM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.