FDA.reportPublic FDA data

Solventum™ Adaptic™

Primary DI
00197998296499
Brand
Solventum™ Adaptic™
Company
Solventum US LLC
Model
2018
Catalog number
2018
Device description
Solventum™ Adaptic™ Non-adhering Dressing, 2018, 3 in x 60 in (7.6 cm x 152.4 cm), 10/CS
Published
2026-04-10
Public version status
New
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
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998296505PackageGS110In Commercial Distribution
00197998296499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998296505001979982965051979982965050197998296505
00197998296499001979982964991979982964990197998296499

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
119004140
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
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00197998054570Solventum™ Tegaderm™90120901202026-04-10
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00197998470455Solventum™ Bair Hugger™90107901072026-04-29
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087114280529543M™ Scotchcast™82299822992026-04-18
087114280529923M™ Scotchcast™82200822002026-04-18
087114280530363M™ Scotchcast™82201822012026-04-18
087114280530503M™ Scotchcast™82202822022026-04-18
040467194325613M™ Scotchcast™82002820022026-04-18
040467194325783M™ Scotchcast™82002A82002A2026-04-18
040467194326223M™ Scotchcast™82002V82002V2026-04-18
040467194326463M™ Scotchcast™82002W82002W2026-04-18
040467194326913M™ Scotchcast™82002B82002B2026-04-18
040467194327143M™ Scotchcast™82002G82002G2026-04-18

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Primary DI, Brand, Company table
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