FDA.reportPublic FDA data

Steriking®

Primary DI
06438263610607
Brand
Steriking®
Company
Wipak Oy
Model
S32
Catalog number
S32
Device description
Single use sterilization packaging
Published
2025-12-30
Public version status
New
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
06438263610607PrimaryGS10
06438263661623Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263610607064382636106076438263610607
06438263661623064382636616236438263661623

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
500
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
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
06438263620286Steriking®SS7SS72025-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437695MilleniumAvalign Technologies, Inc.KCT2026-10-20
00385640095174INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095181INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095198INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095204INSTRUSAFESummit Medical, Inc.KCT2026-10-20
G476STER16X5X1625SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-20
00385640095167INSTRUSAFESummit Medical, Inc.KCT2026-10-16
10886982312327NASynthes GmbHKCT2026-10-16
10886982346704VOLTSynthes GmbHKCT2026-10-16
10886982346735VOLTSynthes GmbHKCT2026-10-16
10886982363282NASynthes GmbHKCT2026-10-16
10886982363299NASynthes GmbHKCT2026-10-16
10886982363305NASynthes GmbHKCT2026-10-16
10886982363312NASynthes GmbHKCT2026-10-16
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