FDA.reportPublic FDA data

Reliance Fusion Light

Primary DI
00841982101657
Brand
Reliance Fusion Light
Company
AHLSTROM NONWOVENS LLC
Model
FL04040
Device description
WLJ1HZ083B, Sterilization Wrap, Reliance Fusion Light, Blue and green bonded alternating sheets, 40 x 40 inches [] 120 applications per case. As used, blue sheet is outer layer.
Published
2024-03-11
Public version status
New
Distribution status
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
K230137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230137000Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC2023-12-07FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841982101657PrimaryGS10
00841982101640Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841982101657008419821016578419821016570841982101657
00841982101640008419821016408419821016400841982101640

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.

Contacts#

Phone, Email table
PhoneEmail
8606548300medical@ahlstrom.com

Regulatory Flags#

DUNS number
039993345
Device count
120
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841982101923Sterilization Wrap, Reliance Solo S600WLJ2Z1170B452024-04-11
00841982101930Sterilization Wrap, Reliance Solo S600WLJ2Z1170B452024-04-11
00841982101893Reliance Fusion HeavyFH054542024-03-12
00841982101886Reliance Fusion HeavyFH054542024-03-12
00841982101534Reliance Fusion LightFL012122024-03-11
00841982101558Reliance Fusion LightFL015152024-03-11
00841982101572Reliance Fusion LightFL018182024-03-11
00841982101596Reliance Fusion LightFL024242024-03-11
00841982101619Reliance Fusion LightFL030302024-03-11
00841982101633Reliance Fusion LightFL036362024-03-11
00841982101671Reliance Fusion LightFL048482024-03-11
00841982101695Reliance Fusion LightFL054542024-03-11
00841982101718Reliance Fusion LightFL054702024-03-11
00841982101794Reliance Fusion HeavyFH024242024-03-11
00841982101831Reliance Fusion HeavyFH036362024-03-11
00841982101855Reliance Fusion HeavyFH040402024-03-11
00841982101879Reliance Fusion HeavyFH048482024-03-11
00841982101916Reliance Fusion HeavyFH054702024-03-11
00841982101527Reliance Fusion LightFL012122024-03-11
00841982101541Reliance Fusion LightFL015152024-03-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00859464007748Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
08404535030792Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
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00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
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