Identity
- Trade Name
- Performa FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Performa Sonishield Antimicrobial Ultrasound Gel 8.5 oz FDA UDI
- Model / Reference
- 081710748 FDA UDI
- Description
- Performa Sonishield Antimicrobial Ultrasound Gel 8.5 oz FDA UDI
Identifiers
- Catalog Number
- 081710748 FDA UDI
- Primary DI / UDI-DI
- 00885914077436 FDA UDI
- 510(k) Number
- K151070 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 8.5 Fluid Ounce FDA UDI
Performa by Performance Health Supply, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Performance Health Supply, LLC
Sources (1)
- FDA UDI e50d9fe1-3fee-4b43-a3c6-5a7c775e4917 38 fields · synced May 30, 2026