Myriad Meshed Expandable Bioscaffold

GUDID 09421908222164

Myriad Meshed™ Expandable Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.

AROA BIOSURGERY LIMITED

Collagen wound matrix dressing

Primary Device ID	09421908222164
NIH Device Record Key	b2d952b6-4cf2-4252-a32a-4d5d8351f4f8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Myriad Meshed Expandable Bioscaffold
Version Model Number	MS01FV1822
Company DUNS	594540572
Company Name	AROA BIOSURGERY LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area
Special Storage Condition, Specify	Between 0 and 0 *Store at room temperature in a clean and dry area

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421908222164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092096

FDA Product Code

KGN	Wound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-12-04
Device Publish Date	2024-11-26

On-Brand Devices [Myriad Meshed Expandable Bioscaffold]

09421908222171	Myriad Meshed™ Expandable Bioscaffold is a sterile, single use ovine forestomach-derived extra
09421908222164	Myriad Meshed™ Expandable Bioscaffold is a sterile, single use ovine forestomach-derived extra