AccessGUDID - DEVICE: Epredia (00673693344692)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Histogel™ Starter Kit 120V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HGSK-2050-1
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693344692
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Histogel™ Starter Kit includes: Wonderblock Aluminum Cooling Blocks, Histogel™, Histogel™ Incubator & Tube Block, Disposable Pipettes and Thermometer (Mercury Free).

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?
46944	Test tube heater	An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.	Active	false
62706	Agar powder IVD	A gelling agent intended to be used to create a solid culture medium for the isolation of single microbial colonies. It is presented as a powdered substance which is added to a heated liquid preparation which cools to form a solid medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEA	Preservative, Cytological

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: a379f0c3-cc2c-4ab9-9fcd-9f96bed3a121
Public Version Date: August 12, 2024
Public Version Number: 1
DI Record Publish Date: August 04, 2024