FDA.reportPublic FDA data

Steriking®

Primary DI
06438263664433
Brand
Steriking®
Company
Wipak Oy
Model
LTR43 NI
Catalog number
LTR43 NI
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
FRGWrap, Sterilization
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221377000
K221379000
K973827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221377000SteriKing LT-Blueline Pouches with TyvekWipak OY2022-12-22FRG
K221379000Steriking LT-Blueline Pouches with TyvekWipak OY2023-01-04FRG
K973827000KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATIONKimberly-Clark Corp.1998-02-11KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438263664433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263664433064382636644336438263664433

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"", ""Hydrogen Peroxide""]"
Ethylene Oxide;Hydrogen Peroxide

Regulatory Flags#

DUNS number
540103855
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817766026355X-Series CaseTecometKCT2026-09-04
00817766026362X-Series CaseTecometKCT2026-09-04
00817766026379X-Series CaseTecometKCT2026-09-04
00817766026386X-Series CaseTecometKCT2026-09-04
00817766026393X-Series CaseTecometKCT2026-09-04
00817766026430X-Series CaseTecometKCT2026-09-04
00817766026447X-Series CaseTecometKCT2026-09-04
00385640094146INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094153INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094160INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094177INSTRUSAFESummit Medical, Inc.KCT2026-08-27
00385640094139INSTRUSAFESummit Medical, Inc.KCT2026-08-26
00724995234232V. MuellerSteris CorporationKCT2026-08-26
00724995234249V. MuellerSteris CorporationKCT2026-08-26
00724995234256V. MuellerSteris CorporationKCT2026-08-26
00724995234263V. MuellerSteris CorporationKCT2026-08-26
00724995234270V. MuellerSteris CorporationKCT2026-08-26
00724995234287V. MuellerSteris CorporationKCT2026-08-26
00724995234294V. MuellerSteris CorporationKCT2026-08-26
00724995234300V. MuellerSteris CorporationKCT2026-08-26
00724995234317V. MuellerSteris CorporationKCT2026-08-26
00724995234324V. MuellerSteris CorporationKCT2026-08-26
00724995234331V. MuellerSteris CorporationKCT2026-08-26
00724995234348V. MuellerSteris CorporationKCT2026-08-26
00724995234355V. MuellerSteris CorporationKCT2026-08-26
00724995234362V. MuellerSteris CorporationKCT2026-08-26
00724995234379V. MuellerSteris CorporationKCT2026-08-26
00724995234386V. MuellerSteris CorporationKCT2026-08-26
00724995234393V. MuellerSteris CorporationKCT2026-08-26
00724995234409V. MuellerSteris CorporationKCT2026-08-26