FDA.reportPublic FDA data

Dukal

Primary DI
10665973032648
Brand
Dukal
Company
Dukal LLC
Model
5501
Catalog number
5501
Device description
Ultrasound Transmission Gel , 20g , Sterile
Published
2026-01-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUIMedia, coupling, ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221999000Ultrasound Transmission GelsHony Medical Co., Ltd.2022-08-30MUI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20665973032645PackageGS1100In Commercial Distribution
30665973032642PackageGS14In Commercial Distribution
10665973032648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2066597303264520665973032645
3066597303264230665973032642
1066597303264810665973032648

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system,) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light, blood gas) that pass through the skin during an examination or treatment. Also known as contact gel, it is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
791014871
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
10855683006705Aquasonic ClearPARKER LABORATORIES INCMUI2026-09-24
10197344130252MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-04-09
10197344130269MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
00197344130279MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
10665973032631DukalDukal LLCMUI2026-01-12
10665973032655DukalDukal LLCMUI2026-01-12
10665973032662DukalDukal LLCMUI2026-01-12
20665973032638DukalDukal LLCMUI2026-01-12
20665973032645DukalDukal LLCMUI2026-01-12
30665973032659DukalDukal LLCMUI2026-01-12
30665973032666DukalDukal LLCMUI2026-01-12
10815112021402E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021433E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021406E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021413E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021420E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021437E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10197106849064CARDINAL HEALTHCardinal Health 200, LLCMUI2025-01-09
10888277629844MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
20888277629841MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
00850030915207RichmarSouth Dakota Partners Inc.MUI2023-08-02
00848340014857Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10848340014854Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10080196306237MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
40080196306238MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
00810113688473ManaMed IncManamed, Inc.MUI2022-12-31
10193489025293MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02
30193489025297MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02