SavvyWire F3001

GUDID 07540184130016

Pre-Shaped Pressure Guidewire

Opsens Inc

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID07540184130016
NIH Device Record Key042f331e-ed0d-4ace-8d29-595020daaf4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSavvyWire
Version Model NumberX-Small
Catalog NumberF3001
Company DUNS253717946
Company NameOpsens Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com
Phone1-833-677-3671
Emailinfo@opsens-medical.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS107540184030019 [Primary]
GS107540184130016 [Package]
Contains: 07540184030019
Package: carton box [5 Units]
In Commercial Distribution
GS107540184230013 [Package]
Contains: 07540184030019
Package: shipping box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-21
Device Publish Date2023-04-13

On-Brand Devices [SavvyWire]

07540184130023Pre-Shaped Pressure Guidewire
07540184130016Pre-Shaped Pressure Guidewire

Trademark Results [SavvyWire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAVVYWIRE
SAVVYWIRE
90030655 not registered Live/Pending
OPSENS INC.
2020-07-01

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