FDA.report

3M™ Actisorb™

Primary DI
04054596955295
Brand
3M™ Actisorb™
Company
3M Deutschland GmbH
Model
190220
Catalog number
190220
Device description
3M™ Actisorb™ Silver 220 Antimicrobial Binding Dressing, 190220, 10.5 cm x 19.0 cm (4.2 in x 7.6 in), 10/Ct, 5 Ct/Cs
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FRODressing, wound, drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054596955295PackageGS15In Commercial Distribution
04054596955288PrimaryGS10
04054596955271Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054596955295040545969552954054596955295
04054596955288040545969552884054596955288
04054596955271040545969552714054596955271

GMDN Terms

TermDefinition
Odour-absorbent dressing, antimicrobialA pad covering for malodourous wounds or lesions (e.g., venous leg ulcers, fungating carcinomas, infected surgical wounds), that absorbs the bad odours typically through a layer of activated charcoal, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. Given the types of wounds to which it is typically applied, the device may also contain a layer that absorbs heavy exudates, and one that minimizes adherence to the wound. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
315731711
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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