FDA.report

3M™ Nu-Gel™

Primary DI
04054596954236
Brand
3M™ Nu-Gel™
Company
3M Deutschland GmbH
Model
MNG425
Catalog number
MNG425
Device description
3M™ Nu-Gel™ Hydrogel with Alginate, MNG425, 0.88 oz (25 g), 6/Ct, 4 Cts/Cs
Published
2023-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NAEDressing, wound, hydrogel without drug and/or biologic

Product Code Classifications

CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054596954236PackageGS11In Commercial Distribution
04054596954229PrimaryGS10
04054596954212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054596954236040545969542364054596954236
04054596954229040545969542294054596954229
04054596954212040545969542124054596954212

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
315731711
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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040545969532223M™ Kerramax Care™PRD500-240PRD500-2402026-01-29
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