AccessGUDID - DEVICE: Marina Medical (00840306804144)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 190-169
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190-169
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306804144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Frazier Dura Hook, Sharp, 12.5 cm / 5 in

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
31052	Assistive dressing/undressing hook/stick	A device typically in the form of a hook with a handle, or a long stick with a handle and a hook at the distal end, designed to be used by a person with a disability to hook, fix, or grasp a garment to manoeuvre and adjust it while dressing or undressing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDG	HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

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
Device Size Text, specify: Length,5,[in_i]

Device Record Status

Public Device Record Key: 98d906e0-eeba-4154-8032-e92426a117f3
Public Version Date: February 21, 2024
Public Version Number: 3
DI Record Publish Date: November 07, 2022