AccessGUDID - DEVICE: UltraCrit Cleaning Tools (00831829000366)

GUDID

Device Identifier (DI) Information

Brand Name: UltraCrit Cleaning Tools
Version or Model: 320-113
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 320-113
Company Name: SEPARATION TECHNOLOGY, INC.

Primary DI Number: 00831829000366
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 195501127 *Terms of Use

Device Description: UltraCrit Cleaning Tools are to be used to clean the UltraCrit and UltraCrit Plus devices.

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
59059	Wash/cleaning solution IVD, manual equipment	A wash or cleaning solution intended to be used in the preparation, decontamination and/or cleanup of equipment (e.g., glassware, weighing equipment) used for the manual processing, staining and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 747e1602-45fe-45da-b76b-a1437ef59690
Public Version Date: June 18, 2018
Public Version Number: 3
DI Record Publish Date: August 25, 2017