AccessGUDID - DEVICE: Corning (H10832861)

GUDID

Device Identifier (DI) Information

Brand Name: Corning
Version or Model: 3286
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3286
Company Name: Corning Incorporated

Primary DI Number: H10832861
Issuing Agency: HIBCC
Commercial Distribution End Date: November 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 001307735 *Terms of Use

Device Description: Corning E-Cube Culture System Kit containing tubings, fittings, filters, and base; without 10-layer CellCube Module, 1 per pack, 1 per case

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:	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?
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
KJA	Flask, 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: 45a5759b-fe21-4385-9d5b-37c58de363e9
Public Version Date: November 09, 2023
Public Version Number: 3
DI Record Publish Date: March 15, 2022