AccessGUDID - DEVICE: Marina Medical (00840306804236)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 190-180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190-180
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306804236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Joseph Skin Hook, Single Prong, Length: 16 cm / 6.25 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?
42595	Soft-tissue surgical hook, reusable	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.	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,6.25,[in_i]

Device Record Status

Public Device Record Key: d2300163-5096-4183-ae20-9d2c5d123b64
Public Version Date: February 21, 2024
Public Version Number: 3
DI Record Publish Date: November 07, 2022