FDA UDI
In Commercial Distribution
🇺🇸 United States
E-Z-GEL UltraSound Gel
DI: 10815112020566
·
Model: 601004
·
BRACCO DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- E-Z-GEL UltraSound Gel
- Primary DI
- 10815112020566
- Version / Model
- 601004
- Catalog Number
- 601004
- Company Name
- BRACCO DIAGNOSTICS INC
- Labeler DUNS
- 849234661
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- c319c39e-8067-43c2-9669-a835d4b7183f
Device Description
EZ Gel 5L
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. 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 | 20815112020563 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 10815112020566 | GS1 | ||||
| Package | 30815112020560 | GS1 | Box | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 609-514-2200
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Liter |