FDA UDI
In Commercial Distribution
🇺🇸 United States
Clear Image Singles Sterile
DI: 30856724004166
·
Model: 04-048-020
·
NEXT MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
288
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Basic Information
- Brand Name
- Clear Image Singles Sterile
- Primary DI
- 30856724004166
- Version / Model
- 04-048-020
- Company Name
- NEXT MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 078566628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 288
- Record Status
- Published
- Publish Date
- 2016-10-24
- Public Version
- 5
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- df299b0f-0c01-4ead-8523-5af61cfa53b1
Device Description
Clear Image Sterile Ultrasound Gel, 20ml
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 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 |
|---|---|---|---|---|---|---|
| Primary | 30856724004166 | GS1 | ||||
| Unit of Use | 10856724004162 | GS1 |