Identity
- Trade Name
- METRON FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- METRON ULTRASOUND GEL, 5L FDA UDI
- Model / Reference
- 303001 FDA UDI
- Description
- METRON ULTRASOUND GEL, 5L FDA UDI
Identifiers
- Catalog Number
- 303001 FDA UDI
- Primary DI / UDI-DI
- 00885914004050 FDA UDI
- 510(k) Number
- K012522 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
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Liter FDA UDI
Category: Skin topical coupling gel
Metron by Performance Health Supply, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Skin topical coupling gel.
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- LG — COMPASS HEALTH BRANDS CORP. · Class II
- Novaplus — NEXT Medical Products Company · Class II
Cleared under the same submission
K012522 also covers:
- CLINICAL HEALTH SERVICES, INC. — CLINICAL HEALTH SERVICES, INC.
- CLINICAL HEALTH SERVICES, INC. — CLINICAL HEALTH SERVICES, INC.
- DynaGel™ Ultrasound Gel, 5 Liters, Blue — Dynatronics Corp.
- DynaGel™ Ultrasound Gel, 5 Liters, Clear — Dynatronics Corp.
- DynaGel™ Ultrasound Gel, sample — Dynatronics Corp.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- AccuGel — LYNN MEDICAL INSTRUMENT CO
- AccuGel — LYNN MEDICAL INSTRUMENT CO
- AccuGel — LYNN MEDICAL INSTRUMENT CO
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 |
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Manufacturer
- Manufacturer
- Performance Health Supply, LLC
Sources (1)
- FDA UDI 21d74a03-2aea-4443-ba7b-651569e2e1b8 37 fields · synced Jun 6, 2026