DEVICE: Epimed (05060224334461)

Device Identifier (DI) Information

Epimed
296-PA06X
In Commercial Distribution
296-PA06X
MINTA MEDICAL LIMITED
05060224334461
GS1

1
232644059 *Terms of Use
Adapter Assembly R-F™ Probe, Stryker Universal
CLOSE

Device Characteristics

MR Unsafe
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?
62025 Percutaneous radio-frequency ablation probe, denervation, monopolar, reusable
A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under x-ray, ultrasound (US) or other external image guidance] to deliver radio-frequency current, in a monopolar configuration, from a system generator directly to peripheral nerve tissues to coagulate/ablate them for the treatment of pain. It includes a distal monopolar electrode which may include temperature-sensing elements; the introduction cannula may be included. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GXI PROBE, RADIOFREQUENCY LESION
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090608 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 0 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

dd4bbd75-5f15-4a93-baae-e1505cc6d653
June 10, 2022
4
October 30, 2017
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)866-3342
customerservice@epimed.com
CLOSE