Sentosa SX101

Basic Information

• Brand Name: Sentosa SX101
• Primary DI: 08885013950007
• Version / Model: 400089
• Catalog Number: 400089
• Company Name: VELA OPERATIONS SINGAPORE PTE. LTD.
• Labeler DUNS: 595361724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-18
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: a96a44f2-4f43-4390-931f-bc32784d9a5f

Device Description

Sentosa SX101 is an automated pipetting instrument designed for contamination-free, precise and correct measuring and transferring of liquids.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	862.2750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60736	Nucleic acid sample preparation instrument IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08885013950007	GS1