FDA UDI
In Commercial Distribution
🇺🇸 United States
Sheathes3D
DI: 10842418104331
·
Model: 65-IL486-22110-3
·
SHEATHING TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Sheathes3D
- Primary DI
- 10842418104331
- Version / Model
- 65-IL486-22110-3
- Company Name
- SHEATHING TECHNOLOGIES, INC.
- Labeler DUNS
- 806806220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-12-14
- Public Version
- 1
- Public Version Date
- 2020-12-22
- Public Version Status
- New
- Public Device Record Key
- 77d81aeb-c758-4fd5-8889-c2599417e2ae
Device Description
Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1cm Face to 15.2cm x 122cm), Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5 & 2.0cm) & Adapter, Tilt-Out Style
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 |
|---|---|---|---|---|
| OIJ | Biopsy Needle Guide Kit | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60443 | Ultrasound/electromagnetic-guided needle kit | A collection of sterile devices intended to be used during a needle entry procedure (e.g., central venous access, aspiration of pneumothorax) that combines ultrasonic and electromagnetic methods for needle guidance (e.g., needle depth data using Hall effect sensors virtually overlaid on ultrasound imaging). It typically includes the needle/cannula with a magnetic attachment, coupling gel, and casing intended to provide a sterile shield for a separate, compatible ultrasound/electromagnetic transducer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20842418104338 | GS1 | Case | 3 | In Commercial Distribution | |
| Primary | 10842418104331 | GS1 | ||||
| Unit of Use | 00842418104334 | GS1 |