AccessGUDID - DEVICE: Marina Medical (00840306835193)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 800-167CLICK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-167CLICK
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306835193
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: 60cc clicker lock for TEURMO style 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":	No
For Single-Use:	No
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?
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	Active	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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: a2b716dd-998c-480b-bbb2-98585633a924
Public Version Date: January 22, 2025
Public Version Number: 2
DI Record Publish Date: October 10, 2024