Myriad Morcells™

GUDID 09421906017915

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

AROA BIOSURGERY LIMITED

Collagen wound matrix dressing
Primary Device ID09421906017915
NIH Device Record Keya48efb32-bb29-4091-a934-902a7c39e832
Commercial Distribution Discontinuation2023-05-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMyriad Morcells™
Version Model NumberPW01NA2000
Company DUNS594540572
Company NameAROA BIOSURGERY LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com
Phone877-627-6224
Emailcustomerservice@aroabio.com

Device Dimensions

Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram
Weight2000 Milligram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS109421906017915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGNDressing, Wound, Collagen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-17
Device Publish Date2023-05-09

On-Brand Devices [Myriad Morcells™]

09421905067928Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421905067911Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017977Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017960Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017953Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017946Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017939Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017922Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017915Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
09421906017908Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.