SERI

Basic Information

• Brand Name: SERI
• Primary DI: B6119467808
• Version / Model: 94678
• Company Name: SOFREGEN MEDICAL INC.
• Labeler DUNS: 079710838
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-02
• Public Version: 4
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: c6675a57-24fa-419c-9c0e-0f17144db579
• Distribution End Date: 2021-12-31

Device Description

SERI Surgical Scaffold 20cm x 30cm

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OXF	Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59088	Extra-gynaecological surgical mesh, silk, bioabsorbable	A bioabsorbable, implantable material (e.g., flat sheet) made from silk (derived from domesticated silkworms) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B6119467808	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123128	000

Device Sizes

Type	Value	Unit	Text
Width	5	Centimeter
Length	15	Centimeter