Identity
- Trade Name
- SheathesTEE FDA UDI
- Generic Name
- Topical coupling gel, sterile FDA UDI
- Device Name
- Polyurethane, 0.7" Tapered to 1.6"W Over 3.7”L x 48"L, Sterile, Ultrasound Probe Cover Gathered on Applicator Tube with 3 Elastics, 20ml Sterile Gel, Bite Block, & 2 Tape Strips FDA UDI
- Model / Reference
- 5-T4040 FDA UDI
- Description
- Polyurethane, 0.7" Tapered to 1.6"W Over 3.7”L x 48"L, Sterile, Ultrasound Probe Cover Gathered on Applicator Tube with 3 Elastics, 20ml Sterile Gel, Bite Block, & 2 Tape Strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10842418104003 FDA UDI
- FDA Product Code
- OIP FDA UDI
- GMDN Term
- Topical coupling gel, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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: Body-orifice ultrasound imaging transducer cover, basicTopical coupling gel, sterile
SheathesTEE by Sheathing Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Topical coupling gel, sterile.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Clear Image Singles Sterile — NEXT Medical Products Company · Class II
- Synergy MSK Ultrasound Strl Cover & Parker Gel — SAFERSONIC Medizinprodukte Handels GmbH · Class II
- Pharmaceutical Innovations — Pharmaceutical Innovations, Inc. · Class II
- PremierPro — SVS LLC · Class II
- Sheathes3D — 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 c4b2becf-5636-4a53-bf17-f9a1264967e3 33 fields · synced Jun 9, 2026