AccessGUDID - DEVICE: O&P Collection Vials Total Fix/C&S Kits (M445890241)

GUDID

Device Identifier (DI) Information

Brand Name: O&P Collection Vials Total Fix/C&S Kits
Version or Model: 890-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 890-24
Company Name: MEDICAL CHEMICAL CORPORATION

Primary DI Number: M445890241
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 008496861 *Terms of Use

Device Description: Convenience kit containing C&S Vials and Total Fix Vials.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
33832	Fixative, metallic	An agent containing metal employed in the preparation of a histologic or pathologic human specimen for the purpose of maintaining the existing form and structure of all of its constituent elements to be used for general diagnostic applications.	Active	false
58564	Carey-Blair transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LDX	Fixative, Metallic Containing
JSM	Culture Media, Non-Propagating Transport

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150887	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73b8f380-14fc-4ee2-946c-1cbd623e4303
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 2020