AccessGUDID - DEVICE: Myriad Morcells™ (09421906017922)

GUDID

Device Identifier (DI) Information

Brand Name: Myriad Morcells™
Version or Model: PW02NA2000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AROA BIOSURGERY LIMITED

Primary DI Number: 09421906017922
Issuing Agency: GS1
Commercial Distribution End Date: May 09, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 594540572 *Terms of Use

Device Description: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.

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 [?]
K200502	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
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Weight: 2000 Milligram

Device Record Status

Public Device Record Key: 724b56d3-da46-481d-8dbc-26c302ce3047
Public Version Date: May 17, 2023
Public Version Number: 1
DI Record Publish Date: May 09, 2023