AccessGUDID - DEVICE: Thermo Fisher (05051663002295)

GUDID

Device Identifier (DI) Information

Brand Name: Thermo Fisher
Version or Model: Histostar
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHANDON DIAGNOSTICS LIMITED

Primary DI Number: 05051663002295
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 219103512 *Terms of Use

Device Description: 100-120V 50/60 Hz

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: 811cd8df-01f3-4049-8e0e-c4e8f041efa3
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: September 25, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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