AccessGUDID - DEVICE: Epredia (05051663518239)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Dispense Nozzle Short
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A81030197
Company Name: SHANDON DIAGNOSTICS LIMITED

Primary DI Number: 05051663518239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 219103512 *Terms of Use

Device Description: HistoStar Tissue Embedding System - Accessory

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?
36416	Tissue embedding unit IVD	An electrically-powered, electronic unit intended to be used in the laboratory for encapsulating (embedding) histologic tissue samples in liquid paraffin wax which when cooled and fixed to a sample holder can be further processed, e.g., placed in a microtome for cutting into samples for microscopy and/or for histological storage. This device will typically have a large storage capacity for the liquid paraffin (e.g., 4 litres) with heating facilities and heated work area, excess paraffin drainage facility, a cold plate area, and possibly a built-in forceps heater.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IDW	Dispensers, Paraffin

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: 2f2bc49c-c4dd-4c64-92a8-2c60ccae48df
Public Version Date: February 23, 2024
Public Version Number: 1
DI Record Publish Date: February 15, 2024