AccessGUDID - DEVICE: Biotronix Healthcare (00850005165040)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronix Healthcare
Version or Model: URHT19
Commercial Distribution Status: In Commercial Distribution
Catalog Number: URHT19
Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Primary DI Number: 00850005165040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065762392 *Terms of Use

Device Description: Irrigation Tray with Piston Syringe

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
63449	Wound irrigation kit, non-sterile	A collection of non-sterile devices intended to be used to irrigate/cleanse an acute or chronic external wound. It consists of multiple items which typically include an irrigation instrument (e.g., syringe, bulb), wipes, towel, drape and/or irrigation solution. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KYZ	Syringe, Irrigating (Non Dental)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: Irrigation Tray with Piston Syringe

Device Record Status

Public Device Record Key: f1dff05e-6800-4ba0-a534-326f100ad480
Public Version Date: December 24, 2019
Public Version Number: 2
DI Record Publish Date: October 04, 2019