FDA.reportPublic FDA data

Steriking®

Primary DI
06438263664112
Brand
Steriking®
Company
Wipak Oy
Model
LTS7520NI
Catalog number
LTS7520NI
Device description
Single use sterilization packaging
Published
2019-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K221377000
K973827000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438263664112PackageGS15In Commercial Distribution
06438263664587PrimaryGS10
06438263664105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263664112064382636641126438263664112
06438263664587064382636645876438263664587
06438263664105064382636641056438263664105

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

Regulatory Flags#

DUNS number
540103855
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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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00653159014246CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014253CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014260CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014277CASE MEDICALCase Medical Inc.KCT2026-06-08
00653159014284CASE MEDICALCase Medical Inc.KCT2026-06-08
07630031779656Straumann Modular CassetteInstitut Straumann AGKCT2026-06-03
00810157315229Basic Surgical KitParagon Implant Mfg., LLCKCT2026-06-02
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
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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
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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