AccessGUDID - DEVICE: ENDORET® PLASMATERM H OVEN (08435389808558)

GUDID

Device Identifier (DI) Information

Brand Name: ENDORET® PLASMATERM H OVEN
Version or Model: PLASMATERM H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOTECHNOLOGY INSTITUTE SL

Primary DI Number: 08435389808558
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 461665312 *Terms of Use

Device Description: No description.

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):	Yes
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?
21087	Forced-air laboratory oven	A mains electricity (AC-powered) device with a heating chamber designed to provide fan-assisted convection to ensure a homogenous temperature profile in the chamber. It is used for laboratory procedures that involve drying, heating, and sterilizing objects. It typically operates at temperatures from 10? Celsius above ambient temperature to 250/300? Celsius. It is available in a variety of designs and chamber sizes, and the chamber is typically lined with corrosion-proof materials (e.g., stainless steel). The device is thermally insulated, has manual or microprocessor-operated controls, heating elements, and time and temperature sensors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 61ed8c0c-b83c-41e9-9f9d-08150d0bf535
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022