AccessGUDID - DEVICE: Wallac Plate Shake (06438147064540)

GUDID

Device Identifier (DI) Information

Brand Name: Wallac Plate Shake
Version or Model: 1296-004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1296-004
Company Name: Wallac Oy

Primary DI Number: 06438147064540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: 1296-004 DELFIA® Plateshake is intended to be used with DELFIA reagents but can also be used for other applications where shaking of microtitration plates is required. One to four plates can be on the shaker simultaneously.

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?
15178	Laboratory shaker	An electromechanical device, typically used in the laboratory or a blood bank, designed to shake/stir samples or mixtures with a rapid and forceful movement. It is used to provide a rapid mixing or to prevent substances comprised of different components from separation or sedimentation because of their different densities. It may be designed to secure single and/or multiple specimen containers (e.g., test tube, microplate) or specimen container holders during the shaking cycle; some types may have selectable agitation frequencies. It may also have a heating function to allow for temperature control of samples.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JRQ	Shaker/Stirrer

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: 79a8364a-41f3-4963-9892-2f19b56c0ab6
Public Version Date: July 25, 2024
Public Version Number: 3
DI Record Publish Date: February 25, 2019