Stablemapr™

GUDID 00763000227906

CATH 04402SM STABLEMAPR W/O CE

MEDTRONIC, INC.

Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use Cardiac mapping catheter, percutaneous, single-use
Primary Device ID00763000227906
NIH Device Record Key437be8ff-93f6-4853-9daf-6f518b79a6de
Commercial Distribution StatusIn Commercial Distribution
Brand NameStablemapr™
Version Model Number04402SM
Company DUNS006261481
Company NameMEDTRONIC, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.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
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
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
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 TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]
GS100763000227906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Stablemapr™]

00643169148024CATH 04402SM STABLEMAPR W/O CE
00643169148000CATH 04401SM STABLEMAPR W/O CE
00763000227913CATH 04401SM STABLEMAPR W/O CE
00763000227906CATH 04402SM STABLEMAPR W/O CE

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.