Restrata(R)

Basic Information

• Brand Name: Restrata(R)
• Primary DI: 00854258006129
• Version / Model: RWM1-1X2
• Company Name: Acera Surgical Inc
• Labeler DUNS: 040631370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-20
• Public Version: 3
• Public Version Date: 2021-09-02
• Public Version Status: Update
• Public Device Record Key: a36f6aac-4c47-44fb-9da9-ecd7afa5de8b

Device Description

Restrata(R) is a sterile, single use device intended for use in local management of wounds. Restrata(R) is a soft, white, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur.

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: Yes
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
34615	Bioabsorbable wound dressing	A sterile wound cover with a bioabsorbable skin contact layer composed of bioengineered/synthetic materials intended to protect a wound and to subsequently be absorbed into the skin as the wound heals. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854258006129	GS1

Device Sizes

Type	Value	Unit	Text
Length	5.0	Centimeter
Width	2.5	Centimeter