AccessGUDID - DEVICE: Marina Medical (00840306834479)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 521-055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 521-055
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306834479
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: 6mm, 40cm Fallopian Ring Applicator

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?
46724	Ophthalmic surgical instrument handle, manual	A hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. 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
Length: 40 Centimeter

Device Record Status

Public Device Record Key: 68f9d147-37c7-4f9b-9cd7-c747e15c8d22
Public Version Date: January 22, 2025
Public Version Number: 2
DI Record Publish Date: September 19, 2024