FDA.reportPublic FDA data

Solventum™ Adaptic™

Primary DI
00197998326653
Brand
Solventum™ Adaptic™
Company
Solventum Germany GmbH
Model
MAD042
Catalog number
MAD042
Device description
Solventum™ Adaptic™ Digit Non-adhering Dressing, MAD042, 3 cm Diameter, X-Large, 10/CAR, 17 CAR/CS, 170/CS
Published
2026-08-26
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

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
00197998326660PackageGS117In Commercial Distribution
00197998326653PrimaryGS10
00197998326646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998326660001979983266601979983266600197998326660
00197998326653001979983266531979983266530197998326653
00197998326646001979983266461979983266460197998326646

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
315518329
Device count
10
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998344046Solventum™MS02MS022026-09-24
00197998344060Solventum™MS01MS012026-09-24
00197998344084Solventum™MS06MS062026-09-24
00197998344107Solventum™MS03MS032026-09-24
00197998344121Solventum™MS04MS042026-09-24
00197998326615Solventum™ Adaptic™MAD003MAD0032026-08-26
00197998367281Solventum™ Adaptic™MAD013MAD0132026-08-26
00197998367359Solventum™ Adaptic™MAD023MAD0232026-08-26
00197998367427Solventum™ Adaptic™MAD062MAD0622026-08-26
00197998152252Solventum™ Tegaderm™90600906002026-08-23
00197998152283Solventum™ Tegaderm™90601906012026-08-23
00197998152313Solventum™ Tegaderm™90602906022026-08-23
00197998152344Solventum™ Tegaderm™90603906032026-08-23
00197998152375Solventum™ Tegaderm™90604906042026-08-23
00197998305801Solventum™ Tegaderm™90817908172026-08-23
00197998305832Solventum™ Tegaderm™90815908152026-08-23
00197998305863Solventum™ Tegaderm™90805908052026-08-23
00197998305894Solventum™ Tegaderm™90803908032026-08-23
00197998305924Solventum™ Tegaderm™90802908022026-08-23
00197998305955Solventum™ Tegaderm™90801908012026-08-23

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Primary DI, Brand, Company table
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