DEVICE: NT1100™ (05415067022370)
Device Identifier (DI) Information
NT1100™
RFG-NT-1100
In Commercial Distribution
RFG-NT-1100
ST. JUDE MEDICAL, INC.
RFG-NT-1100
In Commercial Distribution
RFG-NT-1100
ST. JUDE MEDICAL, INC.
Radiofrequency Generator
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35156 | Percutaneous radio-frequency ablation system generator |
An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXD | GENERATOR, LESION, RADIOFREQUENCY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 18 and 101 KiloPascal |
Handling Environment Temperature: between -10 and 70 Degrees Celsius |
Special Storage Condition, Specify: Keep dry |
Storage Environment Temperature: between 10 and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 69 and 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
21d9008e-75db-4efc-9b3a-15f511495080
June 10, 2022
4
September 20, 2016
June 10, 2022
4
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com