Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- MCK Ultrasnd Gel PINK 5L,ns FDA UDI
- Model / Reference
- 4962 FDA UDI
- Description
- MCK Ultrasnd Gel PINK 5L,ns FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479188416 FDA UDI
- FDA Product Code
- ITX FDA UDIMUI 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
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
Category: Skin topical coupling gel
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI c9435e91-13f4-41fe-b482-79f7e5385a3a 34 fields · synced Jun 8, 2026