AccessGUDID - DEVICE: Epimed (00818788022189)

GUDID

Device Identifier (DI) Information

Brand Name: Epimed
Version or Model: 242-2210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 242-2210
Company Name: EPIMED INTERNATIONAL, INC

Primary DI Number: 00818788022189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799751953 *Terms of Use

Device Description: RF-A B-Bevel 22g x 10cm x 5mm Active Tip Coudé

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
Needle Gauge: 22 Gauge
Length: 5 Millimeter
Length: 10 Centimeter
Device Size Text, specify: 5mm Active Tip
Device Size Text, specify: 22g
Device Size Text, specify: 10cm

Device Record Status

Public Device Record Key: ff9f5ff7-0a5d-478f-8d59-c807d3f88a12
Public Version Date: May 03, 2023
Public Version Number: 3
DI Record Publish Date: November 05, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10818788022186	25	00818788022189		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)866-3342
Email: customerservice@epimed.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES