FDA UDI
In Commercial Distribution
🇺🇸 United States
SheathesISO
DI: 10842418103297
·
Model: 5-70340
·
SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- SheathesISO
- Primary DI
- 10842418103297
- Version / Model
- 5-70340
- Company Name
- SHEATHING TECHNOLOGIES, INC.
- Labeler DUNS
- 806806220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2018-08-01
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 0aa8f403-6c42-4504-b331-cfa609b3a3d4
Device Description
Isoprene, 1.18"D x 11.81"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long
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
- 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 |
|---|---|---|---|---|
| OIP | Radiology-Diagnostic Kit | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60608 | Body-orifice ultrasound imaging transducer cover, basic | A 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 | Active |
| 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 | 20842418103294 | GS1 | CASE | 3 | In Commercial Distribution | |
| Primary | 10842418103297 | GS1 | ||||
| Unit of Use | 00842418103290 | GS1 |