FDA.reportPublic FDA data

Dukal

Primary DI
10665973017218
Brand
Dukal
Company
Dukal LLC
Model
273
Catalog number
273
Device description
Iodoform Packing Strip 2" x 5 yd
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
EFQGAUZE/SPONGE, INTERNAL
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940339000IODOFORM PACKAGING STRIPAlbahealth Products1994-02-25FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10665973017218PackageGS112In Commercial Distribution
20665973017215PackageGS112In Commercial Distribution
00665973017211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066597301721810665973017218
2066597301721520665973017215
00665973017211006659730172116659730172110665973017211

GMDN Terms#

Term, Definition table
TermDefinition
Gauze strip, antimicrobialA thin length of sterile woven material (e.g., cotton, cellulose) that is impregnated with an antimicrobial agent (e.g., iodoform) and primarily designed to pack draining wounds to absorb exudates. It may be soaked with other medication (not included) before application. 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
10665973027347Dukal27602276022022-12-06
10665973032198RENCURARCCA66RCCA662024-11-04
10665973032259RENCURARCCS48RCCS482024-11-04
10665973029488UnipackUGC-6600-LUGC-6600-L2022-12-06
10665973029495UnipackUGC-6600-MUGC-6600-M2022-12-06
10665973029501UnipackUGC-6600-SUGC-6600-S2022-12-06
10665973029518UnipackUGC-6600-XLUGC-6600-XL2022-12-06
10665973029525UnipackUGC-6600-XXLUGC-6600-XXL2022-12-06
10665973029532UnipackUGC-6601-LUGC-6601-L2022-12-06
10665973029549UnipackUGC-6601-MUGC-6601-M2022-12-06
10665973029556UnipackUGC-6601-SUGC-6601-S2022-12-06
10665973029563UnipackUGC-6601-XLUGC-6601-XL2022-12-06
10665973029570UnipackUGC-6601-XXLUGC-6601-XXL2022-12-06
10665973029587UnipackUGC-6602-LUGC-6602-L2022-12-06
10665973029594UnipackUGC-6602-MUGC-6602-M2022-12-06
10665973029600UnipackUGC-6602-SUGC-6602-S2022-12-06
10665973029617UnipackUGC-6602-XLUGC-6602-XL2022-12-06
10665973029624UnipackUGC-6602-XXLUGC-6602-XXL2022-12-06
10665973029631UnipackUGC-6603-LUGC-6603-L2022-12-06
10665973029648UnipackUGC-6603-MUGC-6603-M2022-12-06

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00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
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