Restella

Basic Information

• Brand Name: Restella
• Primary DI: 09421904065987
• Version / Model: R20243-1018P
• Company Name: AROA BIOSURGERY LIMITED
• Labeler DUNS: 594540572
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-30
• Public Version: 7
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 2f63caff-bb62-4038-99c6-b8947fc55261
• Distribution End Date: 2020-04-30

Device Description

Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	878.3300	2
FTM	Mesh, Surgical	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61545	Extra-gynaecological surgical mesh, biologic-polymer composite	A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) 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	09421904065987	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 25 – 25 Degrees Celsius