Identity
- Trade Name
- Ultrashcallsondenabdeckung EUDAMEDSheathes Pre-Gelled FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Non-Sterile Ultrasound Probe Cover EUDAMEDPolyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Un-Rolled with Pull Tab, Extra-Long, Individually Wrapped FDA UDI
- Model / Reference
- 27690-PT EUDAMEDFDA UDI
- Description
- Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Un-Rolled with Pull Tab, Extra-Long, Individually Wrapped FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842418102538 EUDAMED10842418102535 FDA UDI
- Basic UDI-DI
- 08424181C1PNSA9 EUDAMED
- FDA Product Code
- OIP FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Skin topical coupling gelBody-orifice ultrasound imaging transducer cover, basic
Sheathes Pre-Gelled by Sheathing Technologies, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Body-orifice ultrasound imaging transducer cover, basic.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (2)
- FDA UDI 5affb85f-5804-43bd-9dc8-643d8b322c5e 33 fields · synced Jul 8, 2026
- EUDAMED 6110a8cc-2f8b-451e-adf2-97d77964cd82 61 fields · synced Jul 8, 2026