FDA.reportPublic FDA data

Oasis

Primary DI
D830OM3090
Brand
Oasis
Company
AMD Medicom Inc
Model
OM3090
Device description
"Oasis P646 HS 3""x9"" (1200/CS)"
Published
2017-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953829000SAFE-T-SEALGs Medical Packaging, Inc.1995-11-09KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D830OM30901PackageHIBCC200In Commercial Distribution
D830OM30902PackageHIBCC6In Commercial Distribution
D830OM3090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
9052711523accounting@gsmedicalpackaging.com

Regulatory Flags#

DUNS number
256880576
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864044434AMD-RITMED85992C85992C2019-01-15
10686864044441AMD-RITMED85993C85993C2019-01-15
10686864044458AMD-RITMED85994C85994C2019-01-15
10686864044465AMD-RITMED85995C85995C2019-01-15
10686864044472AMD-RITMED85996C85996C2019-01-15
10686864044489AMD-RITMED85997C85997C2019-01-15
10686864044496AMD-RITMED85998C85998C2019-01-15
20686864043205AMD-RITMED55992C55992C2019-01-15
20686864043212AMD-RITMED55993C55993C2019-01-15
20686864043229AMD-RITMED55994C55994C2019-01-15
20686864043236AMD-RITMED55995C55995C2019-01-15
20686864043243AMD-RITMED55996C55996C2019-01-15
20686864043250AMD-RITMED55997C55997C2019-01-15
20686864043267AMD-RITMED55998C55998C2019-01-15
10686864061950Ocean Pacific NeoNatural1228B-SP101228B-SP102026-07-13
10686864061967Ocean Pacific NeoNatural1228C-SP101228C-SP102026-07-13
10686864061974Ocean Pacific NeoNatural1228D-SP101228D-SP102026-07-13
10686864061868MEDICOM SAFESEAL76112761122026-06-25
10686864061875MEDICOM SAFESEAL76115761152026-06-25
10686864061899MEDICOM SAFESEAL76020760202026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095082INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095099INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095105INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095112INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095129INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095136INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095143INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095150INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00724995239909V. MuellerSteris CorporationKCT2026-10-15
00724995239916V. MuellerSteris CorporationKCT2026-10-15
00724995239923V. MuellerSteris CorporationKCT2026-10-15
00724995239930V. MuellerSteris CorporationKCT2026-10-15
00724995239947V. MuellerSteris CorporationKCT2026-10-15
00724995240660V. MuellerSteris CorporationKCT2026-10-15
00724995240677V. MuellerSteris CorporationKCT2026-10-15
00724995240684V. MuellerSteris CorporationKCT2026-10-15
00724995240691V. MuellerSteris CorporationKCT2026-10-15
00724995240707V. MuellerSteris CorporationKCT2026-10-15
00724995241025V. MuellerSteris CorporationKCT2026-10-15
00724995241049V. MuellerSteris CorporationKCT2026-10-15
00724995241056V. MuellerSteris CorporationKCT2026-10-15
00724995241063V. MuellerSteris CorporationKCT2026-10-15
00724995241070V. MuellerSteris CorporationKCT2026-10-15
00724995241087V. MuellerSteris CorporationKCT2026-10-15
00724995241094V. MuellerSteris CorporationKCT2026-10-15
00724995241100V. MuellerSteris CorporationKCT2026-10-15
00724995241117V. MuellerSteris CorporationKCT2026-10-15
00724995241131V. MuellerSteris CorporationKCT2026-10-15
00724995241148V. MuellerSteris CorporationKCT2026-10-15
00724995241155V. MuellerSteris CorporationKCT2026-10-15