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WALLACH® Summit Doppler™ Ultrasound Gel 250 grams
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- WALLACH® Summit Doppler™ Ultrasound Gel 250 grams FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- WALLACH® Summit Doppler™ Ultrasound Gel 250 grams FDA UDI
- Model / Reference
- G155 FDA UDI
- Description
- WALLACH® Summit Doppler™ Ultrasound Gel 250 grams FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937017076 FDA UDI
- FDA Product Code
- MUI FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin topical coupling gel
WALLACH® Summit Doppler™ Ultrasound Gel 250 grams by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- CooperSurgical, Inc.
Sources (2)
- FDA UDI d376ad39-98c9-4cfe-b8cc-573c7742e95f 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026