Myriad Morcells™

GUDID 09421906017977

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 ID09421906017977
NIH Device Record Keyc1c54e7f-3a0e-47be-ba35-915ea21be282
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyriad Morcells™
Version Model NumberPW02NA0050
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

Device Dimensions

Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 Milligram
Weight50 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
GS109421906017977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGNWound Dressing With Animal-Derived Material(S)

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

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