AccessGUDID - DEVICE: Twisted Pair Needle Electrode (00852373007083)

GUDID

Device Identifier (DI) Information

Brand Name: Twisted Pair Needle Electrode
Version or Model: 003-400124-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 003-400124-3
Company Name: SGM d.o.o.

Primary DI Number: 00852373007083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 499490357 *Terms of Use

Device Description: Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	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
IKT	Electrode, Needle, Diagnostic Electromyograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010019	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
Length: 12 Millimeter
Length: 2 Meter

Device Record Status

Public Device Record Key: a42e6315-0d7b-4d30-9739-2b8e40a37f7e
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00852373007090	250	00852373007083	In Commercial Distribution	Carton Box
00852373007151	100	00852373007083	In Commercial Distribution	Carton Box
00852373007144	350	00852373007083	In Commercial Distribution	Carton Box
00852373007175	300	00852373007083	In Commercial Distribution	Carton Box