FDA.reportPublic FDA data

Reliance Fusion Heavy

Primary DI
00841982101909
Brand
Reliance Fusion Heavy
Company
AHLSTROM NONWOVENS LLC
Model
FH05470
Device description
WLJ2HZ132B, Sterilization Wrap, Reliance Fusion Heavy, Blue and green bonded alternating sheets, 54 x 72 inches [] 24 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
Rx
false
OTC
false
Sterile
false
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
00841982101916PrimaryGS10
00841982101909Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841982101916008419821019168419821019160841982101916
00841982101909008419821019098419821019090841982101909

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

Contacts#

Phone, Email table
PhoneEmail
8606548300medical@ahlstrom.com

Regulatory Flags#

DUNS number
039993345
Device count
24
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00841982101657Reliance Fusion LightFL040402024-03-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
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00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
00840456201923JMUJMU DENTAL, INCFRG2026-06-05
00840456201930JMUJMU DENTAL, INCFRG2026-06-05
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00840456202968JMUJMU DENTAL, INCFRG2026-06-05
00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
00840456207208JMUJMU DENTAL, INCFRG2026-06-05
00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05