Identity
- Trade Name
- Aquaflex FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Profound 3cm narrow gel pad FDA UDI
- Model / Reference
- ULTRASOUND GEL PAD FDA UDI
- Description
- Profound 3cm narrow gel pad FDA UDI
Identifiers
- Catalog Number
- 04-95-820311 FDA UDI
- Primary DI / UDI-DI
- 00303410000036 FDA UDI
- 510(k) Number
- K851895 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Skin topical coupling gel
Aquaflex by Parker Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K851895 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
Sources (1)
- FDA UDI c0074a91-af0f-4950-b485-e0d00303313a 36 fields · synced May 30, 2026