FDA.reportPublic FDA data

Solventum™ Tegaderm™

Primary DI
00197998054532
Brand
Solventum™ Tegaderm™
Company
Solventum US LLC
Model
90110
Catalog number
90110
Device description
Solventum™ Tegaderm™ High Integrity Alginate Dressing, 90110, 2 in x 2 in (5 cm x 5 cm), 100 BAG/CS
Published
2026-04-10
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
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998054556PackageGS1100In Commercial Distribution
00197998054532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998054556001979980545561979980545560197998054556
00197998054532001979980545321979980545320197998054532

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
119004140
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998095641Transpore™1527-01527-02026-09-25
00197998095672Transpore™1527-11527-12026-09-25
00197998095702Transpore™1527-21527-22026-09-25
00197998095733Transpore™1527-31527-32026-09-25
00197998095788Transpore™1527S-11527S-12026-09-25
00197998103612Transpore™1534-1241534-1242026-09-25
00197998103636Transpore™1534S-21534S-22026-09-25
00197998164118Transpore™1527S-21527S-22026-09-25
00197998302718Solventum™21174211742026-09-25
00197998001246Solventum™ Tegaderm™1877-21001877-21002026-08-23
00197998001277Solventum™ Tegaderm™1879-21001879-21002026-08-23
00197998001369Solventum™ Tegaderm™166416642026-08-23
00197998002861Solventum™ Tegaderm™9132NS9132NS2026-08-23
00197998149016Solventum™ Tegaderm™358435842026-08-23
00197998149047Solventum™ Tegaderm™358235822026-08-23
00197998149078Solventum™ Tegaderm™358735872026-08-23
00197998149382Solventum™ Tegaderm™358635862026-08-23
00197998149412Solventum™ Tegaderm™359335932026-08-23
00197998149443Solventum™ Tegaderm™359035902026-08-23
00197998149474Solventum™ Tegaderm™358835882026-08-23

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Primary DI, Brand, Company table
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