FDA.reportPublic FDA data

Defend

Primary DI
00843471131695
Brand
Defend
Company
Young Innovations, Inc.
Model
SW-1500
Catalog number
SW-1500
Device description
Disposable Sterilization Wrap (CSR) 15 Inch x 15 Inch
Published
2022-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K143637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143637000U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd.2015-09-09FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843471131692PackageGS11000Not in Commercial Distribution
00843471131695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347113169210843471131692
00843471131695008434711316958434711316950843471131695

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container linerA non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843471120460DefendVP-8104VP-81042022-10-30
00843471120477DefendVP-8104TVP-8104T2022-10-30
00843471120484DefendVP-8105VP-81052022-10-30
00843471120491DefendVP-8105TVP-8105T2022-10-30
00843471120514DefendVP-8106VP-81062022-10-30
00843471120521DefendVP-8106TVP-8106T2022-10-30
00843471120538DefendVP-8107VP-81072022-10-30
00843471120545DefendVP-8108VP-81082022-10-30
00843471120552DefendVP-8108TVP-8108T2022-10-30
00843471120569DefendVP-8111VP-81112022-10-30
00843471120576DefendVP-8111TVP-8111T2022-10-30
00843471120583DefendVP-8140VP-81402022-10-30
00843471120590DefendVP-8140TVP-8140T2022-10-30
00843471120606DefendVP-8150TVP-8150T2022-10-30
00843471120637DefendVP-8165TVP-8165T2022-10-30
00843471143926Defend2926272926272022-10-30
00843471152782DefendCS-0100CS-01002022-10-30
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535037654Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
08404535037685Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-20
00724995239985V. MuellerSteris CorporationFRG2026-10-15
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20884389188269GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188256GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190426GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190453GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115498GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277188270GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277190440GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389188283GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190484GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115597GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
10884389192481GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196180810GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921093GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921116GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190419GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277115580GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20888277190471GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26