AccessGUDID - DEVICE: Bio Protech (00817120020678)

GUDID

Device Identifier (DI) Information

Brand Name: Bio Protech
Version or Model: NDBH
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIO PROTECH USA, INC.

Primary DI Number: 00817120020678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789127011 *Terms of Use

Device Description: NDBH: Monopolar single use pencil, 2 button; holster; needle electrode; L 3m (1 pc per pack, 20 packs in a inner box, 40 packs in a master case)

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):	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?
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
IKT	Electrode, Needle, Diagnostic Electromyograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 95f28327-345a-4e47-b1be-7e703a501ab2
Public Version Date: June 11, 2018
Public Version Number: 3
DI Record Publish Date: June 06, 2017