Identity
- Trade Name
- Sheathes FDA UDI
- Generic Name
- Ultrasound/electromagnetic-guided needle kit FDA UDI
- Device Name
- Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1cm Face to 15.2cm x 244cm) 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 FDA UDI
- Model / Reference
- 65-IL966-22110-3 FDA UDI
- Description
- Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 96"L (2.5cm x 8.1cm Face to 15.2cm x 244cm) 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10842418104355 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Ultrasound/electromagnetic-guided needle kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasound/electromagnetic-guided needle kit
Sheathes by Sheathing Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound/electromagnetic-guided needle kit.
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (1)
- FDA UDI 2af8fb31-10e9-4c75-b473-de4f58e8834d 33 fields · synced Jun 9, 2026