AccessGUDID - DEVICE: Epredia (05051663003872)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: NX70 with HOMPD, 220-240V
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 957050L
Company Name: SHANDON DIAGNOSTICS LIMITED

Primary DI Number: 05051663003872
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 219103512 *Terms of Use

Device Description: Cryostar NX70 Cryostat

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?
15157	Cryostat microtome IVD	A precision cutting instrument contained within a temperature-controlled cabinet (i.e., a cryostat) intended to be used for the sectioning of rapidly-frozen tissue specimens without prior fixation to expedite subsequent in vitro diagnostic analysis of the tissue specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IDP	Microtome, Cryostat

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: cb8c1591-8317-417c-bc3f-ba02140d8cde
Public Version Date: February 23, 2024
Public Version Number: 1
DI Record Publish Date: February 15, 2024