FDA UDI
In Commercial Distribution
🇺🇸 United States
PremierPro
DI: 00818566012852
·
Model: 3401
·
PRESTIGE AMERITECH, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- PremierPro
- Primary DI
- 00818566012852
- Version / Model
- 3401
- Company Name
- PRESTIGE AMERITECH, LTD.
- Labeler DUNS
- 199692794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-01
- Public Version
- 4
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- 960bf331-35a4-4cc8-a836-cb1bb8904d81
Device Description
Ultrasound Gel, 20g Packet, Sterile
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 58735 | Topical coupling gel, sterile | A sterile medium designed to be applied to a patient's skin surface to provide a coupling between an ultrasound transducer and the patient, allowing for the emission and reception of ultrasonic waves that pass through the skin during an ultrasound examination requiring sterile procedure. It is in the form of a non-sticky, drip resistant, fluid-like gel that has been thermally sterilized (contains no degradation products of radiation sterilization) that also assists the operator's ability to move the ultrasound transducer (probe) smoothly over the skin to better scan the site of interest. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20818566012856 | GS1 | Case | 5 | In Commercial Distribution | |
| Package | 10818566012859 | GS1 | Box | 48 | In Commercial Distribution | |
| Primary | 00818566012852 | GS1 |
Customer Contacts
- Phone
- 1-855-531-7699
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Direct Sunlight