FDA.reportPublic FDA data

Dukal

Primary DI
20665973017178
Brand
Dukal
Company
Dukal LLC
Model
222
Catalog number
222
Device description
Oil Emulsion Dressing 3" x 8"
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850241000ALBA HEALTH CARE NON-ADHERING DRESSINGAlba Health Care1985-03-12FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10665973017171PackageGS136In Commercial Distribution
20665973017178PackageGS16In Commercial Distribution
00665973017174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066597301717110665973017171
2066597301717820665973017178
00665973017174006659730171746659730171740665973017174

GMDN Terms#

Term, Definition table
TermDefinition
Petrolatum woven gauze pad, sterileA sterile, non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973027279Dukal27610276102022-12-06
00665973016917Tech-Med201020102016-09-24
00665973016993Tech-Med2010C2010C2016-09-24
10665973018314American White Cross141003314100332022-12-06
10665973027354Dukal27603276032022-12-06
10665973027262Dukal27609276092022-12-06
10665973032860DUKALUPST-050UPST-0502026-06-01
10665973032877DUKALUPST-075UPST-0752026-06-01
10665973032884DUKALUPST-100UPST-1002026-06-01
10665973027248Dukal27607276072022-12-06
20665973026675Dukal60409604092022-12-06
00665973027456Dukal700710470071042022-12-06
10665973032631Dukal550055002026-01-12
10665973032648Dukal550155012026-01-12
10665973032655Dukal550255022026-01-12
10665973032662Dukal550355032026-01-12
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12

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00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
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