FDA.reportPublic FDA data

Steriking®

Primary DI
06438263620316
Brand
Steriking®
Company
Wipak Oy
Model
SS-T3A
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
06438263620132PackageGS15In Commercial Distribution
06438263620316PrimaryGS10
06438263660497Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438263620132064382636201326438263620132
06438263620316064382636203166438263620316
06438263660497064382636604976438263660497

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
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
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26
00810194403699AiraAIRA, LLCFRG2026-08-26
00810194403712AiraAIRA, LLCFRG2026-08-26
00810194403729AiraAIRA, LLCFRG2026-08-26
00810194403736AiraAIRA, LLCFRG2026-08-26
08404535030853Brasseler USAPeter Brasseler Holdings, LLCFRG2026-08-21
10724995233386V. MuellerSteris CorporationFRG2026-08-21
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
20680651497639HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497646HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497653HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497660HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14