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Ultrasound Gel Pack, Overwrapped Sterilized Chevron Pouch
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60400
Identity
- Trade Name
- SheathesGel FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Ultrasound Gel Pack, Overwrapped Sterilized Chevron Pouch EUDAMEDSterile, 20ml Single-Use Packet of Ultrasound Gel Inside Chevron Pouch FDA UDI
- Model / Reference
- 60400 EUDAMEDFDA UDI
- Description
- Sterile, 20ml Single-Use Packet of Ultrasound Gel Inside Chevron Pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-60400SHETHESEJ EUDAMED10842418100760 FDA UDI
- Basic UDI-DI
- B-60400SHETHESEJ 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
Ultrasound Gel Pack, Overwrapped Sterilized Chevron Pouch by Sheathing Technologies, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-60400SHETHESEJ | 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 082d42dc-98db-44d4-be79-35a03066d145 61 fields · synced Jun 18, 2026
- FDA UDI 26a156b4-7a0d-458e-b9b4-7d824b3603a9 34 fields · synced May 30, 2026