AccessGUDID - DEVICE: Myriad Ultra™ Reinforced BioScaffold

GUDID

Device Identifier (DI) Information

Brand Name: Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)
Version or Model: LP04PP1525
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LP04PP1525
Company Name: AROA BIOSURGERY LIMITED

Primary DI Number: 09421906661897
Issuing Agency: GS1
Commercial Distribution End Date: May 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 594540572 *Terms of Use

Device Description: Myriad Ultra ™ Reinforced Tissue Matrix is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). Myriad™ is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired.

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?
61545	Extra-gynaecological surgical mesh, biologic-polymer composite	A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric
FTM	Mesh, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153632	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
Width: 15 Centimeter
Length: 20 Centimeter

Device Record Status

Public Device Record Key: 921cda27-b9ef-43b0-be00-a8a54a3f56c3
Public Version Date: May 29, 2024
Public Version Number: 2
DI Record Publish Date: November 28, 2022