AccessGUDID - DEVICE: CELLSTAR (14039943002249)

GUDID

Device Identifier (DI) Information

Brand Name: CELLSTAR
Version or Model: 660160-TRI
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 660160-TRI
Company Name: Greiner Bio - One GmbH

Primary DI Number: 14039943002249
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315685714 *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?
44904	Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIZ	DISH, TISSUE CULTURE

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: dd517f78-c056-4de7-85a1-6f25a67b1edd
Public Version Date: July 31, 2024
Public Version Number: 3
DI Record Publish Date: December 06, 2022