Identity
- Trade Name
- SheathesISO FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Isoprene, 1.18"D x 11.81"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long FDA UDI
- Model / Reference
- 5-70340 FDA UDI
- Description
- Isoprene, 1.18"D x 11.81"L, Sterile, Ultrasound Probe Cover with 20ml Sterile Gel & 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10842418103297 FDA UDI
- FDA Product Code
- OIP FDA UDI
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic 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
SheathesISO by Sheathing Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (1)
- FDA UDI 0aa8f403-6c42-4504-b331-cfa609b3a3d4 33 fields · synced Jun 9, 2026