AccessGUDID - DEVICE: Symphony™ Proliferative Bioscaffold (09421907331560)

GUDID

Device Identifier (DI) Information

Brand Name: Symphony™ Proliferative Bioscaffold
Version or Model: CM03HA048R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CM03HA048R
Company Name: AROA BIOSURGERY LIMITED

Primary DI Number: 09421907331560
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 594540572 *Terms of Use

Device Description: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular matrix.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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?
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Dressing, Wound, Collagen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200413	000

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
Device Size Text, specify: 8 cm x 6 cm

Device Record Status

Public Device Record Key: 3423393d-4d03-46c8-af2e-8536d7c98715
Public Version Date: May 01, 2024
Public Version Number: 2
DI Record Publish Date: March 28, 2024