Endoform Natural Dermal Template 529313

GUDID 09421904065635

Endoform Natural Dermal Template 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 ID09421904065635
NIH Device Record Keyc475dd8a-0580-4cca-8d62-d0b0a83c804e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoform Natural Dermal Template
Version Model Number529313
Catalog Number529313
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

Device Dimensions

Length10 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *clean and dry area, away from direct light

Device Identifiers

Device Issuing AgencyDevice ID
GS109421904065475 [Primary]
GS109421904065536 [Package]
Contains: 09421904065475
Package: CARTON [10 Units]
In Commercial Distribution
GS109421904065635 [Package]
Contains: 09421904065536
Package: SHIPPER [50 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-06
Device Publish Date2018-03-31

On-Brand Devices [Endoform Natural Dermal Template]

09421904065642Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
09421904065635Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
09421905067324Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
09421905067331Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
09421905067362Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
09421905067355Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
09421904065659Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
09421904065628Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula

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