AccessGUDID - DEVICE: CELLPRESERV KOLPLAST (07898027907630)

GUDID

Device Identifier (DI) Information

Brand Name: CELLPRESERV KOLPLAST
Version or Model: CELLPRESERV CYTOCENTRIFUGE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10.1315
Company Name: Kolplast C I

Primary DI Number: 07898027907630
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 903963889 *Terms of Use

Device Description: No description.

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?
35881	Cytological centrifuge IVD	An electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IFB	Cytocentrifuge

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: 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: 2f88845a-8351-4ab4-a22e-01f5aaf70686
Public Version Date: December 07, 2023
Public Version Number: 1
DI Record Publish Date: November 29, 2023