AccessGUDID - DEVICE: CELLPRESERV KOLPLAST (07898027900792)

GUDID

Device Identifier (DI) Information

Brand Name: CELLPRESERV KOLPLAST
Version or Model: FILTRO GIN CELLPRESERV
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10.1347
Company Name: Kolplast C I

Primary DI Number: 07898027900792
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:	Yes
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?
63871	Microfilter imaging plate IVD	A plate with multiple wells, a selectively permeable microfilter membrane and an optically clear base, intended to be used for microfiltration and capture of target molecules (e.g., DNA oligonucleotides) for subsequent analysis and/or imaging during an in vitro diagnostic procedure. It is typically made of plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KET	Filters, Cell Collection, Tissue Processing

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: 9bbfa1fe-3645-4d54-85bc-c76de108f2b9
Public Version Date: December 07, 2023
Public Version Number: 1
DI Record Publish Date: November 29, 2023