FDA UDI
In Commercial Distribution
🇺🇸 United States
EZCOVER® Gel-Vision
DI: 05407006210757
·
Model: PCG15061-02
·
MedXPress.Pro
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- EZCOVER® Gel-Vision
- Primary DI
- 05407006210757
- Version / Model
- PCG15061-02
- Company Name
- MedXPress.Pro
- Labeler DUNS
- 371406782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-28
- Public Version
- 1
- Public Version Date
- 2024-04-05
- Public Version Status
- New
- Public Device Record Key
- 91385659-d094-4c45-9016-22246d7f7a69
Device Description
EZCOVER® Gel-Vision 61 cm long
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
- No
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44713 | Body-surface ultrasound imaging transducer cover | A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05407006210764 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 05407006210757 | GS1 | ||||
| Package | 05407006210771 | GS1 | Case | 180 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191491 | 000 |