AccessGUDID - DEVICE: Epimed International, Inc. (00818788020413)

GUDID

Device Identifier (DI) Information

Brand Name: Epimed International, Inc.
Version or Model: 268-2010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 268-2010
Company Name: EPIMED INTERNATIONAL, INC

Primary DI Number: 00818788020413
Issuing Agency: GS1
Commercial Distribution End Date: August 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 799751953 *Terms of Use

Device Description: RF™ Coudé® Blunt 20g TW x 10cm with 15mm Active Tip

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
GXI	Probe, radiofrequency lesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041021	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20g
Length: 15 Millimeter
Needle Gauge: 20 Gauge
Device Size Text, specify: 15mm Active Tip
Length: 10 Centimeter
Device Size Text, specify: 10cm

Device Record Status

Public Device Record Key: 6db65dcb-d975-4ce2-9713-5561f434e348
Public Version Date: August 03, 2023
Public Version Number: 4
DI Record Publish Date: April 05, 2022