AccessGUDID - DEVICE: Micro C Load Bearing Cassette Plate, ACSY-S009 (00860008892751)

GUDID

Device Identifier (DI) Information

Brand Name: Micro C Load Bearing Cassette Plate, ACSY-S009
Version or Model: ACSY-S009
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OXOS Medical, Inc.

Primary DI Number: 00860008892751
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080323883 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
64687	Flat panel x-ray detector/film cassette weight-bearing protector	A device intended to cover a flat panel x-ray detector or film cassette (neither included) on which a patient stands, to protect the cassette/detector from the patient’s body weight during a computed or digital radiography procedure of the feet. It is made of radiolucent materials with low x-ray attenuation/scattering. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZL	System, X-Ray, Mobile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212654	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ccb7f4de-08c6-4f7e-8170-0d354e0f20af
Public Version Date: December 30, 2024
Public Version Number: 2
DI Record Publish Date: October 19, 2022