AccessGUDID - DEVICE: Restrata Meshed (00854258006297)

GUDID

Device Identifier (DI) Information

Brand Name: Restrata Meshed
Version or Model: RMESH-4X5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Acera Surgical Inc

Primary DI Number: 00854258006297
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040631370 *Terms of Use

Device Description: The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.

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?
64853	Synthetic wound matrix dressing	A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.	Active	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
No Device Sizes

Device Record Status

Public Device Record Key: 1507814e-7f5b-4704-8a5c-56b96dc19604
Public Version Date: April 29, 2022
Public Version Number: 1
DI Record Publish Date: April 21, 2022