AccessGUDID - DEVICE: Starrsed Cleaning Agent (08719189137132)

GUDID

Device Identifier (DI) Information

Brand Name: Starrsed Cleaning Agent
Version or Model: QRR010905
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RR Mechatronics Manufacturing B.V.

Primary DI Number: 08719189137132
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 491828953 *Terms of Use

Device Description: Product for cleaning pipettes in Starrsed ESR analyzers

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
58236	Buffered wash solution IVD	A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKB	DEVICE, AUTOMATED SEDIMENTATION RATE

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical

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: 5bf26ad3-a3b6-4c75-8e7b-657dde596ec0
Public Version Date: August 02, 2023
Public Version Number: 1
DI Record Publish Date: July 25, 2023