FDA UDI
In Commercial Distribution
🇺🇸 United States
Sheathes3D
DI: 10842418102115
·
Model: 70340VCI
·
SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Sheathes3D
- Primary DI
- 10842418102115
- Version / Model
- 70340VCI
- Company Name
- SHEATHING TECHNOLOGIES, INC.
- Labeler DUNS
- 806806220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-08-18
- Public Version
- 5
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- fd1395c4-db70-4166-b9c8-5651bf7e11cc
Device Description
Polyurethane, 1.18"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Straight, Narrow, Rolled, Extra-Long
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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10842418102115 | GS1 | ||||
| Unit of Use | 00842418100930 | GS1 | ||||
| Package | 20842418102112 | GS1 | CASE | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153212 | 000 |