FDA.reportPublic FDA data

Steriking®

Primary DI
06438263660381
Brand
Steriking®
Company
WIPAK PACKAGING (CHANGSHU) CO., LTD.
Model
SS5A
Catalog number
SS5A
Device description
Single use sterilization packaging
Published
2016-09-23
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
K953776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953776000STERIKING STERILIZATION POUCHES & ROLLSWihuri OY1995-10-12KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438263661999PackageGS15In Commercial Distribution
06438263660381PrimaryGS10
06438263663627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263661999064382636619996438263661999
06438263660381064382636603816438263660381
06438263663627064382636636276438263663627

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
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438263660114Steriking®LTSS5ALTSS5A2016-09-26
06438263660138Steriking®LTSS4LTSS42016-09-26
06438263660367Steriking®SS6SS62016-09-23
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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10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23