Identity
- Trade Name
- SheathesGel FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Sterile Ultrasound Gel Pack EUDAMEDInternally Sterile, 20ml Single-Use Packet of Ultrasound Gel FDA UDI
- Model / Reference
- 60001 EUDAMEDFDA UDI
- Description
- Internally Sterile, 20ml Single-Use Packet of Ultrasound Gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-60001SHEATHES8V EUDAMED10842418102122 FDA UDI
- Basic UDI-DI
- B-60001SHEATHES8V EUDAMED
- 510(k) Number
- K130041 FDA UDI
- FDA Product Code
- MUI FDA UDI
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Sterile Ultrasound Gel Pack by Sheathing Technologies, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-60001SHEATHES8V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
- EUDAMED SRN
- US-MF-000044559
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e9cc233a-09ac-40b8-aabf-36de5ef17ac2 61 fields · synced Jun 19, 2026
- FDA UDI cf9eb550-9648-4ef3-9a06-b24661027824 34 fields · synced May 30, 2026