DEVICE: ClosureRFG™ (10884521777545)

Device Identifier (DI) Information

ClosureRFG™
RFG3
In Commercial Distribution

MEDTRONIC, INC.
10884521777545
GS1

1
006261481 *Terms of Use
GENERATOR RFG3 CLOSUREFAST
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. 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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, cutting & coagulation & accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141858 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Special Storage Condition, Specify: Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
Special Storage Condition, Specify: 500 - 1060 hPa
Special Storage Condition, Specify: Keep Dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

cad5e9c1-df29-4033-9036-3477f42faa16
June 10, 2022
2
August 10, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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