FDA.reportPublic FDA data

OASIS Micro

Primary DI
20827002587636
Brand
OASIS Micro
Company
COOK BIOTECH INCORPORATED
Model
G58763
Catalog number
CS-500MG
Device description
Micronized Wound Matrix
Published
2020-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
K152033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152033000Cook ECM PowderCook Biotech Incorporated2015-08-19KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20827002587636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2082700258763620827002587636

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. 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.
Special Storage Condition, Specify00Store in clean, dry location at room temperature
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
945385862
Device count
1
Lot or batch
true
Expiration date on label
true

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
09421908222522Symphony™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222553Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222560Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222577Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222584Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222591Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222607Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222614Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222621Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222638Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222645Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222652Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222669Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222676Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222683Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222690Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222706Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
07610221017621DermaFormGeistlich Pharma AGKGN2026-10-19
00810226442979Vive CareVIVE HEALTH LLCKGN2026-10-14
00850083365035LaviorLavior Pharma Inc.KGN2026-10-08
00850083365042LaviorLavior Pharma Inc.KGN2026-10-08
00850083365059LaviorLavior Pharma Inc.KGN2026-10-08
00850065122236VitaleCELLERA LLCKGN2026-10-01
00850088144963CARBOUNingbo kehu Medical Technology Co.,Ltd.KGN2026-09-30
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18