DEVICE: RFTL (04048223070710)

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Device Record History
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Device Identifier (DI) Information
RFTL
001165-11D
In Commercial Distribution
001165-11D
Pajunk GmbH Medizintechnologie
04048223070710
GS1

1
317654283 *Terms of Use
RFTL 20G x 52,6mm stimulation tip 5mm, grinding 15°,
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Device Characteristics
MR Unsafe
No
No
Yes
No
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?
58739 Percutaneous radio-frequency ablation probe cannula, single-use
A rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GXI Probe, radiofrequency lesion
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K060397 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Length: 52.6 Millimeter
Needle Gauge: 20.0 Gauge
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Device Record Status
9c2f463b-a38d-4b3d-9a56-67c5927141e4
December 01, 2025
2
January 30, 2025
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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
04048223050132 25 04048223070710 In Commercial Distribution
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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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1 770-493-6832
info@pajunk-usa.com
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