FDA UDI
In Commercial Distribution
🇺🇸 United States
Sheathes Pre-Gelled
DI: 10842418102573
·
Model: 47090
·
SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- Sheathes Pre-Gelled
- Primary DI
- 10842418102573
- Version / Model
- 47090
- Company Name
- SHEATHING TECHNOLOGIES, INC.
- Labeler DUNS
- 806806220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2018-07-24
- Public Version
- 3
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- f36b438d-af5b-4d3d-a8db-3182707b73c4
Device Description
Polyurethane, 1"D x 8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover with 5" Debris Shield, Vaginal/Rectal, Tapered, Rolled, Individually Wrapped
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
- No
- 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 |
|---|---|---|---|---|
| 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 |
| 60609 | Body-orifice ultrasound imaging transducer cover, basic, non-sterile | A non-sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20842418102570 | GS1 | CASE | 6 | In Commercial Distribution | |
| Primary | 10842418102573 | GS1 | ||||
| Unit of Use | 00842418102576 | GS1 |