FDA.reportPublic FDA data

OASIS

Primary DI
00810179632731
Brand
OASIS
Company
COOK BIOTECH INCORPORATED
Model
G57604
Catalog number
8213-3000-16
Device description
OASIS Burn Matrix
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNDressing, wound, collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061711000OASIS WOUND MATRIXCook Biotech, Inc.2006-07-19KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810179632738PackageGS15In Commercial Distribution
00827002576049PreviousGS10
00810179632731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017963273810810179632738
00827002576049008270025760498270025760490827002576049
00810179632731008101796327318101796327310810179632731

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.

Contacts#

Phone, Email table
PhoneEmail
+1(765)497-3355CBIRegulatory@evergenbio.com

Regulatory Flags#

DUNS number
945385862
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810179630065AxoGuardG52789AG02202026-07-31
00810179630089AxoGuardG52790AG03202026-07-31
00810179630102AxoGuardG52791AG03402026-07-31
00810179630126AxoGuardG52792AG05202026-07-31
00810179630140AxoGuardG52804AG05402026-07-31
00810179630164AxoGuardG52803AG07202026-07-31
00810179630188AxoGuardG52802AG07402026-07-31
00810179630201AxoGuardG52801AG10202026-07-31
00810179630225AxoGuardG52800AG10402026-07-31
00810179630263AxoGuardG35128AGX1152026-07-31
00810179630287AxoGuardG52798AGX2102026-07-31
00810179630300AxoGuardG35130AGX2152026-07-31
00810179630324AxoGuardG52797AGX3102026-07-31
00810179630348AxoGuardG35131AGX3152026-07-31
00810179630362AxoGuardG52796AGX4102026-07-31
00810179630386AxoGuardG35132AGX4152026-07-31
00810179630409AxoGuardG52795AGX5102026-07-31
00810179630423AxoGuardG35133AGX5152026-07-31
00810179630447AxoGuardG52794AGX6102026-07-31
00810179630461AxoGuardG35134AGX6152026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632656OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632663OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632670OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632687OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632694OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632700OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632717OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632748OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632755OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632762OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
09421908222515Myriad Meshed Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-07-04
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02
00850084084034CURCOFR TECH, LLCKGN2026-06-02