AccessGUDID - DEVICE: Marina Medical (00840306812156)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 190-163
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190-163
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306812156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Fomon Retractor, Single Ball, 16cm / 6.25 in

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?
57817	Comedo expressor	A manual instrument designed for pressing or squeezing out a comedo (black head) from the mouth of sebaceous follicles. It typically consists of a hand-held device with one or both ends appropriately configured (e.g., crimped, spoon-like, forming loops) for the extraction of plugging comedos. The instrument is used in the treatment of acne; it may be used also for plantar warts. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAL	RETRACTOR, ENT

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, 16cm

Device Record Status

Public Device Record Key: 982e805b-e666-4b52-98e2-1a44273cb836
Public Version Date: February 07, 2024
Public Version Number: 1
DI Record Publish Date: January 30, 2024