AccessGUDID - DEVICE: Marina Medical (00840306812316)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 020-075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 020-075
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306812316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Solution Bowl, 35 x 11.5 x 2cm

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?
13692	Sponge bowl, reusable	A receptacle specifically designed to store and/or collect sponges; it may be used to collect sponges during a surgical procedure. It is typically made of stainless steel and can be used for multiple patients after appropriate sterilization. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: 855a07a5-a83d-4bea-8015-4ed9778100f1
Public Version Date: January 16, 2025
Public Version Number: 2
DI Record Publish Date: February 13, 2024