AccessGUDID - DEVICE: Marina Medical (00840306811043)

GUDID

Device Identifier (DI) Information

Brand Name: Marina Medical
Version or Model: 033-010B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 033-010B
Company Name: MARINA MEDICAL INSTRUMENTS, INC.

Primary DI Number: 00840306811043
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011442279 *Terms of Use

Device Description: Keyes Dermal Biopsy Punch Set, 2-8mm

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?
61481	Open-surgery biopsy forceps, single-use	A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRY	PUNCH, SURGICAL

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: 15 cm / 6 in

Device Record Status

Public Device Record Key: 50893cce-232b-478b-ab7e-ed79a33b93a2
Public Version Date: February 04, 2025
Public Version Number: 2
DI Record Publish Date: January 30, 2024