FDA.reportPublic FDA data

Steriking®

Primary DI
06438263620293
Brand
Steriking®
Company
Wipak Oy
Model
SS-T1
Catalog number
SS-T1
Device description
Single use sterilization packaging
Published
2016-09-14
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
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K803293000
K953776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K803293000GUARDIAN PEEL POUCHESKimberly-Clark Corp.1981-01-28FRG
K953776000STERIKING STERILIZATION POUCHES & ROLLSWihuri OY1995-10-12KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438263620118PackageGS15In Commercial Distribution
06438263620293PrimaryGS10
06438263660510Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263620118064382636201186438263620118
06438263620293064382636202936438263620293
06438263660510064382636605106438263660510

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

Regulatory Flags#

DUNS number
540103855
Device count
200
Combination product
true
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
06438263667267Steriking®RR432026-02-02
06438263667274Steriking®RR452026-02-02
06438263667281Steriking®RR492026-02-02
06438263666901Steriking®RR41RR412025-12-30
06438263667250Steriking®RR41RR412025-12-30
06438264180031Steriking®RR43RR432025-12-30
06438264180055Steriking®RR45RR452025-12-30
06438264180062Steriking®RR49RR492025-12-30
06438263610508Steriking®S20S202025-12-30
06438263610607Steriking®S32S322025-12-30
06438263610843Steriking®S34S34-3P2025-12-30
06438263610966Steriking®S23S232025-12-30
06438263620194Steriking®SS10SS102025-12-30
06438263620200Steriking®SS1SS12025-12-30
06438263620217Steriking®SS2SS22025-12-30
06438263620224Steriking®SS3SS32025-12-30
06438263620231Steriking®SS4SS42025-12-30
06438263620248Steriking®SS4ASS4A2025-12-30
06438263620262Steriking®SS5ASS5A2025-12-30
06438263620279Steriking®SS6SS62025-12-30

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Primary DI, Brand, Company table
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00840456201831JMUJMU DENTAL, INCFRG2026-06-05
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00840456201862JMUJMU DENTAL, INCFRG2026-06-05
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00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05