FDA.report

Dukal

Primary DI
20665973005991
Brand
Dukal
Company
Dukal LLC
Model
4070
Catalog number
4070
Device description
Island Dressing 2" x 3"
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20665973005991PackageGS150In Commercial Distribution
30665973005998PackageGS18In Commercial Distribution
10665973005994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2066597300599120665973005991
3066597300599830665973005998
1066597300599410665973005994

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags

DUNS number
791014871
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
20665973033024Dukal553055302026-02-26
20665973020918Dukal11130111302026-01-30
20665973020932Dukal11127111272026-01-30
30665973032611Dukal986098602025-10-31
30665973032628Dukal986198612025-10-31
30665973032598DukalK-10040K-100402025-09-18
30665973032451UnipackUPP-1015UPP-10152025-06-01
30665973032475UnipackUPP-223UPP-2232025-06-01
30665973032482UnipackUPP-225UPP-2252025-06-01
30665973032499UnipackUPP-29UPP-292025-06-01
30665973032505UnipackUPP-3212UPP-32122025-06-01
30665973032512UnipackUPP-3565UPP-35652025-06-01
30665973032529UnipackUPP-4212UPP-42122025-06-01
30665973032536UnipackUPP-5211UPP-52112025-06-01
30665973032543UnipackUPP-5275UPP-52752025-06-01
30665973032550UnipackUPP-7513UPP-75132025-06-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07333350377205Mepore®Mölnlycke Health Care ABNAC2026-05-23
07333350625993Mepore®Mölnlycke Health Care ABNAC2026-05-23
00361554003412Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003436Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003450Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
20197344025340MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-13
30197344016840MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
30197344016857MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
07333350045845Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
07333350416249Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
20665973033024DukalDukal LLCNAC2026-02-26
00197998275326Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275951Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275999Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276033Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276071Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276118Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276156Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276194Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276231Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276279Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998276316Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00810178883646ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883653ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883660ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883677ViveCareVIVE HEALTH LLCNAC2026-02-05
20197344016812MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
20197344016836MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
00198926007453OrchidQuest USA Corp.NAC2026-02-03
00198926007460OrchidQuest USA Corp.NAC2026-02-03