Who else makes this device?

Name: Restella
Brand: Restella

General & Plastic Surgery › ProstheticMesh, Surgical, Polymeric

Restella

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…

Registry build 21.09.26

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.

1manufacturer

12catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code FTL
Manufacturer	City	Province	Registered as	Device types
Shanghai Suokang Medical Implants Co., Ltd.	Shang Hai	Shanghai	Manufacturer	2

Record

Regulatory record for Restella
Listed by	Aroa Biosurgery Ltd, New Zealand
FDA product code	FTL
Device type	Mesh, Surgical, Polymeric
Device class	Class 2
Regulation	21 CFR 878.3300
Establishment	Contract manufacturer, Complaint-file establishment, Manufacturer
Record published	2019-04-30
Record revised	2022-06-10 (version 7)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 25 to 25 °C
Distribution end date	2020-04-30

Catalogue Numbers

Catalogue numbers for Restella
Catalogue number	Size	Status
R20253-0815G		Withdrawn
R20143-0416P		Withdrawn
R20153-1620G		Withdrawn
R20243-0717P		Withdrawn
R20243-1018P		Withdrawn
R20143-2020P		Withdrawn
R20343-1622P		Withdrawn
R20343-2022P		Withdrawn
R30353-2022G		Withdrawn
R20153-0416G		Withdrawn
R20253-1122G		Withdrawn
R20253-1020G		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Technical Products	Technical Products, Inc.	143
Parietex	Sofradim Production	82
DynaMesh	FEG Textiltechnik Forschungs- und Entwicklungsges. mbH	45
Symbotex	Sofradim Production	35
Silicone Sheeting Reinforced	Bentec Medical OpCo, LLC.	33
Parietene	Sofradim Production	32
C-QUR	Atrium Medical Corporation	31
ProGrip	Sofradim Production	31
Silicone Sheeting Non-Reinforced	Bentec Medical OpCo, LLC.	31
Prolite	Atrium Medical Corporation	31
Gore Seamguard Bioabsorbable Staple Line Reinforce	W. L. Gore & Associates, Inc.	30
Surgimesh®wn	Aspide Medical	28

Showing 12 of 148. All products under Mesh, Surgical, Polymeric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181935	2018-12-04

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P990028	2003-12-04	FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT	Genzyme Corporation

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.