FDA.reportPublic FDA data

Dukal

Primary DI
10665973017225
Brand
Dukal
Company
Dukal LLC
Model
263
Catalog number
263
Device description
Plain Packing Strip 2" x 5yd
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFQGauze/Sponge, InternalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861154000ALBA HEALTH CARE PLAIN PACKING STRIPAlba Health Care1986-04-15EFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10665973017225PackageGS112In Commercial Distribution
20665973017222PackageGS112In Commercial Distribution
00665973017228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066597301722510665973017225
2066597301722220665973017222
00665973017228006659730172286659730172280665973017228

GMDN Terms#

Term, Definition table
TermDefinition
Gauze strip, non-antimicrobialA thin length of non-medicated sterile woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with 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
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
10665973029655UnipackUGC-6603-SUGC-6603-S2022-12-06
10665973029662UnipackUGC-6603-XLUGC-6603-XL2022-12-06
10665973029679UnipackUGC-6603-XXLUGC-6603-XXL2022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253047509CurityCardinal Health 200, LLCEFQ2026-04-08
50192253067888ASOCardinal Health 200, LLCEFQ2026-01-20
B960RED202RED Prep-KitNeuraxis, Inc.EFQ2025-01-09
00630094194110Bioseal Inc.BIOSEALEFQ2023-10-11
10192253047523CurityCardinal Health 200, LLCEFQ2023-10-09
10192253047561CurityCardinal Health 200, LLCEFQ2023-10-09
00665973017228DukalDukal LLCEFQ2022-12-06
00665973017235DukalDukal LLCEFQ2022-12-06
00665973017242DukalDukal LLCEFQ2022-12-06
00683534830017A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830024A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830031A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830048A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830055A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830062A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830079A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830086A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830093A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830109A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830116A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830123A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830130A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830147A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830154A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830161A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830178A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830185A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830277A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830284A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19
00683534830307A PlusA PLUS INTERNATIONAL INC.EFQ2022-10-19