AccessGUDID - DEVICE: Steelco (08051160654888)

GUDID

Device Identifier (DI) Information

Brand Name: Steelco
Version or Model: ID 300/2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ID 300/2
Company Name: STEELCO SPA

Primary DI Number: 08051160654888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428717469 *Terms of Use

Device Description: This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.

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?
35575	General-purpose drying cabinet	A mains electricity (AC-powered) device designed for the controlled warming and drying of a variety of items and products, including medical devices. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls; some types may include an extractor/air circulation fan and air filters. This is a freestanding cabinet (tabletop or floor design) typically used in a laboratory or hospital reprocessing unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRJ	Unit, Drying

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: 8a38152c-16ea-401d-96d3-116021530ebc
Public Version Date: November 13, 2020
Public Version Number: 1
DI Record Publish Date: November 05, 2020