FDA UDI
In Commercial Distribution
🇺🇸 United States
Sheathes3D
DI: 10842418103525
·
Model: 5-IA366
·
SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Sheathes3D
- Primary DI
- 10842418103525
- Version / Model
- 5-IA366
- Company Name
- SHEATHING TECHNOLOGIES, INC.
- Labeler DUNS
- 806806220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2018-08-08
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- e445dffc-cc02-438f-a7cf-e6cd181bc8ac
Device Description
Seamless Viral Barrier Burr End, Polyurethane, 1.2"D Tapered to 6"W x 36"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 20ml Sterile Gel & 2 Elastics, Telescopically Folded
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OIP | Radiology-Diagnostic Kit | Radiology | 892.1680 | 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 |
| 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 | 20842418103522 | GS1 | CASE | 3 | In Commercial Distribution | |
| Primary | 10842418103525 | GS1 | ||||
| Unit of Use | 00842418103528 | GS1 |