FDA.reportPublic FDA data

Steriking®

Primary DI
06438263660664
Brand
Steriking®
Company
WIPAK PACKAGING (CHANGSHU) CO., LTD.
Model
LTS2550
Catalog number
LTS2550Y
Device description
Single use sterilization packaging
Published
2016-09-26
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
K973827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973827000KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATIONKimberly-Clark Corp.1998-02-11KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438263644428PackageGS13In Commercial Distribution
06438263660664PrimaryGS10
06438263663481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263644428064382636444286438263644428
06438263660664064382636606646438263660664
06438263663481064382636634816438263663481

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
"[""Hydrogen Peroxide"", ""Ethylene Oxide""]"

Regulatory Flags#

DUNS number
543001936
Device count
200
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
06438263660114Steriking®LTSS5ALTSS5A2016-09-26
06438263660138Steriking®LTSS4LTSS42016-09-26
06438263660367Steriking®SS6SS62016-09-23
06438263660381Steriking®SS5ASS5A2016-09-23
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095372INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095389INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095396INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095402INSTRUSAFESummit Medical, Inc.KCT2026-10-29
07899995223999ORGANIZER BOX VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237705Organizer Box Intraoral Pro Scanning PremiumSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237712Beyond Full Arch Surgical KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237729Intraoral Pro Scanning Premium KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237736Intraoral Pro Scanning Starter KitSin Sistema de Implante Nacional S/AKCT2026-10-29
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006680Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006697Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006703Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006710Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006734Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006758Mastel SurgicalMastel Surgical Inc.KCT2026-10-23