FDA.reportPublic FDA data

Steriking®

Primary DI
06438263660114
Brand
Steriking®
Company
WIPAK PACKAGING (CHANGSHU) CO., LTD.
Model
LTSS5A
Catalog number
LTSS5A
Device description
Single use sterilization packaging
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K973827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973827000KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATIONKimberly-Clark Corp.1998-02-11KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438263663078PackageGS15In Commercial Distribution
06438263660114PrimaryGS10
06438263663757Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263663078064382636630786438263663078
06438263660114064382636601146438263660114
06438263663757064382636637576438263663757

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.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Ethylene Oxide""]"

Regulatory Flags#

DUNS number
543001936
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438263660138Steriking®LTSS4LTSS42016-09-26
06438263660367Steriking®SS6SS62016-09-23
06438263660381Steriking®SS5ASS5A2016-09-23
06438263660398Steriking®SS4ASS4A2016-09-23
06438263660404Steriking®SS4SS42016-09-23
06438263660411Steriking®SS2SS22016-09-23
06438263660428Steriking®SS1SS12016-09-23
06438263660435Steriking®SS10SS102016-09-23
06438263660534Steriking®SS3SS32016-09-23
06438263660657Steriking®LTS7520LTS7520Y2016-09-26
06438263660664Steriking®LTS2550LTS2550Y2016-09-26
06438263660671Steriking®LTS2538LTS2538Y2016-09-26
06438263660688Steriking®LTS2038LTS2038Y2016-09-26
06438263660695Steriking®LTS1530LTS1530Y2016-09-26
06438263660701Steriking®LTS1025LTS1025Y2016-09-26
06438263660107Steriking®LTSS7LTSS72016-09-26
06438263663078Steriking®LTSS5ALTSS5A2016-09-26
06438263660121Steriking®LTSS4ALTSS4A2016-09-26
06438263663092Steriking®LTSS4LTSS42016-09-26
06438263660145Steriking®LTSS1LTSS12016-09-26

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Primary DI, Brand, Company table
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00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
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00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
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07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23