AccessGUDID - DEVICE: Spes Medica Subdermal Needle Electrodes (18054655016649)

GUDID

Device Identifier (DI) Information

Brand Name: Spes Medica Subdermal Needle Electrodes
Version or Model: TT03MN4013D/25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPES MEDICA SPA

Primary DI Number: 18054655016649
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 514029771 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXZ	Electrode, Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192603	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 87c0e508-b7fd-4a1a-8a8e-f7c9044cfdee
Public Version Date: February 21, 2025
Public Version Number: 2
DI Record Publish Date: January 28, 2020