FDA UDI
In Commercial Distribution
🇺🇸 United States
Dukal
DI: 10665973032662
·
Model: 5503
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Dukal
- Primary DI
- 10665973032662
- Version / Model
- 5503
- Catalog Number
- 5503
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-12
- Public Version
- 2
- Public Version Date
- 2026-03-17
- Public Version Status
- Update
- Public Device Record Key
- 10ca4c16-be08-4b68-9a5f-47c3cd820d0a
Device Description
Ultrasound Transmission Gel , 5L , Non-Sterile
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUI | Media, coupling, ultrasound | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15321 | Skin topical coupling gel | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30665973032666 | GS1 | Case | 2 | In Commercial Distribution | |
| Primary | 10665973032662 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241789 | 000 |