AccessGUDID - DEVICE: Restrata(R) (00854258006129)

GUDID

Device Identifier (DI) Information

Brand Name: Restrata(R)
Version or Model: RWM1-1X2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Acera Surgical Inc

Primary DI Number: 00854258006129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040631370 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 5.0 Centimeter
Width: 2.5 Centimeter

Device Record Status

Public Device Record Key: a36f6aac-4c47-44fb-9da9-ecd7afa5de8b
Public Version Date: September 02, 2021
Public Version Number: 3
DI Record Publish Date: May 20, 2019