AccessGUDID - DEVICE: Micro SSP™ Gel System

GUDID

Device Identifier (DI) Information

Brand Name: Micro SSP™ Gel System - 108 Wells
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MGS108
Company Name: ONE LAMBDA, INC.

Primary DI Number: 00814695024452
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118289289 *Terms of Use

Device Description: The Micro SSP Gel Box System is a compact gel box for electrophoresis.

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):	Yes
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?
60407	Electrophoresis chamber IVD	An electrically-powered manual laboratory apparatus intended to be used for the qualitative and/or quantitative in vitro determination of various substances, especially proteins, in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJN	Apparatus, Electrophoresis, For Clinical 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
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a1d84d6-978b-4fc8-9630-228e89b59642
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: June 15, 2018