Guidewire with PTFE coating 21115

GUDID 04044508116869

Oscor Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID04044508116869
NIH Device Record Keyfc28e10b-7f5c-4209-814a-df94e47ba0f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuidewire with PTFE coating
Version Model Number21115
Catalog Number21115
Company DUNS101835833
Company NameOscor Inc.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch
Length180 Centimeter
Outer Diameter0.035 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104044508116869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-07-23
Device Publish Date2017-11-21

Devices Manufactured by Oscor Inc.

00885672101466 - Guidewire2023-09-15 Guidewire with PTFE coating
10885672102576 - ATAR D-R X2L2023-09-08 Disposable Extension Cable
00885672012489 - Baylis Med Tech Passport Steerable Sheath2023-03-23 Passport Steerable Sheath 6.5F
00885672012496 - Baylis Med Tech Passport Steerable Sheath2023-03-23 Passport Steerable Sheath 6.5F
00885672012502 - Baylis Med Tech Passport Steerable Sheath2023-03-23 Passport Steerable Sheath 6.5F
00885672012519 - Baylis Med Tech Passport Steerable Sheath2023-03-23 Passport Steerable Sheath 6.5F
00885672012526 - Baylis Med Tech Passport Steerable Sheath2023-03-23 Passport Steerable Sheath 6.5F
00885672012533 - Baylis Med Tech Passport Steerable Sheath2023-03-23 Passport Steerable Sheath 6.5F Dual Dilator

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