Seraplas

Basic Information

• Brand Name: Seraplas
• Primary DI: 04038917081528
• Version / Model: 53.428
• Catalog Number: 53.428
• Company Name: Sarstedt Aktiengesellschaft & Co.KG
• Labeler DUNS: 388000270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-09-17
• Public Version: 4
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 810e3394-be6b-4119-8a1f-cedaa8daa392

Device Description

Seraplas V15

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63765	Assay container liner IVD	A device intended to be used to create a barrier between the assay container and devices used for aspirating and/or depositing (e.g., pipette), to prevent reagent carryover and spillage, during in vitro diagnostic procedures. It may be used to perforate a sealed single or multichannel assay container and create a working channel for subsequent liquid handling. It is typically made of synthetic polymer materials (e.g., plastic) as a single component, or a strip of multiple liners. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038917081528	GS1
Unit of Use	04038917163842	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]