FDA UDI
In Commercial Distribution
🇺🇸 United States
Sheathes3D
DI: 10842418104591
·
Model: 5-1245-IL486
·
SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Sheathes3D
- Primary DI
- 10842418104591
- Version / Model
- 5-1245-IL486
- Company Name
- SHEATHING TECHNOLOGIES, INC.
- Labeler DUNS
- 806806220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-12-13
- Public Version
- 3
- Public Version Date
- 2026-03-24
- Public Version Status
- Update
- Public Device Record Key
- de21525a-206b-46f0-aecc-dc0ccdc07c95
Device Description
5-1245-IL486, Bag, Polyurethane, 1" x 3.2" Face to 6"W x 48"L, Probe Cover with a 4.5"W x 12"L Ultrasound Probe Cover, Sterile, with 20ml Sterile Gel & 2 Elastics, Rolled
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 |
|---|---|---|---|---|
| 44714 | Intraoperative ultrasound imaging transducer cover | A sterile sheath 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 imaging system transducer (probe) used intraoperatively, e.g., on internal organs, 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 | 20842418104598 | GS1 | Case | 3 | In Commercial Distribution | |
| Primary | 10842418104591 | GS1 | ||||
| Unit of Use | 00842418104594 | GS1 |