FDA.reportPublic FDA data

Solventum™ Nu-Gel™

Primary DI
00197998326882
Brand
Solventum™ Nu-Gel™
Company
Solventum Germany GmbH
Model
MNG415
Catalog number
MNG415
Device description
Solventum™ Nu-Gel™ Hydrogel with Alginate, MNG415, 0.52 oz (15 g),10/CAR, 4 CAR/CS, 40/CS
Published
2025-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAEDressing, wound, hydrogel without drug and/or biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998326905PackageGS140In Commercial Distribution
00197998326882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998326905001979983269051979983269050197998326905
00197998326882001979983268821979983268820197998326882

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
315518329
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998079917Solventum™ Durelon™38236382362026-10-08
00197998079955Solventum™ Durelon™38237382372026-10-08
00197998079962Solventum™ Durelon™38019380192026-10-08
00197998079986Solventum™ Durelon™38216382162026-10-08
00197998079993Solventum™ Durelon™38234382342026-10-08
00197998080005Solventum™ Durelon™38235382352026-10-08
00197998099984Solventum™ RelyX™56660566602026-10-08
00197998226724Solventum™ Protemp™46962469622026-10-08
00197998226731Solventum™ Protemp™46973469732026-10-08
00197998226748Solventum™ Protemp™46964469642026-10-08
00197998226755Solventum™ Protemp™46963469632026-10-08
00197998226762Solventum™ Protemp™46961469612026-10-08
00197998226779Solventum™ Protemp™46958469582026-10-08
00197998226786Solventum™ Protemp™46955469552026-10-08
00197998226809Solventum™ Paradigm™46995469952026-10-08
00197998226816Solventum™ Paradigm™46994469942026-10-08
00197998226823Solventum™ Paradigm™46993469932026-10-08
00197998226847Solventum™ Garant™77581775812026-10-08
00197998029844Solventum™ Micropore™2770K-12770K-12026-10-05
00197998344046Solventum™MS02MS022026-09-24

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Primary DI, Brand, Company table
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08809319802631HyFer HerNonMOON-X USA, Inc.NAE2026-08-03
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00850083365028LaviorLavior Pharma Inc.NAE2026-07-17
06970206829191PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206820808kegel Hydrogel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-22
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00850060751738SkinPenBellus Medical, LLCNAE2026-05-20
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21