FDA.reportPublic FDA data

ADAPTIC® DIGIT

Primary DI
15051978010050
Brand
ADAPTIC® DIGIT
Company
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Model
MAD042U
Catalog number
MAD042U
Device description
Non Adhering Digit Dressing
Published
2019-09-24
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

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
25051978010057PackageGS110In Commercial Distribution
15051978010050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505197801005725051978010057
1505197801005015051978010050

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
211352227
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051978001089FIBRACOL® PLUS298129812019-09-24
15051978001096FIBRACOL® PLUS298229822019-09-24
15051978001102FIBRACOL® PLUS298329832019-09-24
15051978001119FIBRACOL® PLUS298429842019-09-24
15051978002833PROMOGRAN PRISMA®MA028MA0282019-09-24
15051978002888PROMOGRAN PRISMA®MA123MA1232019-09-24
15051978003083PROMOGRAN®PG004PG0042019-09-24
15051978003090PROMOGRAN®PG019PG0192019-09-24
15051978009993PROMOGRAN PRISMA®MA032MA0322019-09-24
15051978003427DYNA-FLEX™70252018-09-24
15051978006428BIOCLUSIVE® PLUSBIP0607BIP06072019-09-24
15051978006435BIOCLUSIVE® PLUSBIP1012BIP10122019-09-24
15051978006442BIOCLUSIVE® PLUSBIP1520BIP15202019-09-24
15051978006459BIOCLUSIVE® PLUSBIP2030BIP20302019-09-24
15051978002543NU-DERM® HCB102HCB1022019-09-24
15051978002550NU-DERM® HCB106HCB1062019-09-24
15051978002567NU-DERM® HCS100HCS1002019-09-24
15051978002574NU-DERM®HCT101HCT1012019-09-24
15051978002581NU-DERM® HCB108HCB1082019-09-24
15051978002604NU-DERM® HCB204HCB2042019-09-24

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Primary DI, Brand, Company table
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00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
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09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22