Identity
- Trade Name
- LEADER FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- Advanced Healing; Blister Bandages; Waterproof; Flexible Comfort; Lasts up to 7x Longer; Great for Blisters; Hydrocolloid Construction; Large Bandages 1 1/8 IN. x 2 3/8 IN. FDA UDI
- Model / Reference
- 3463098 FDA UDI
- Description
- Advanced Healing; Blister Bandages; Waterproof; Flexible Comfort; Lasts up to 7x Longer; Great for Blisters; Hydrocolloid Construction; Large Bandages 1 1/8 IN. x 2 3/8 IN. FDA UDI
Identifiers
- Catalog Number
- 3463098 FDA UDI
- Primary DI / UDI-DI
- 00096295111699 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Leader by Cardinal Health 110, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 110, Inc.
Sources (1)
- FDA UDI 663fb88f-6ad9-43b0-96d2-a083f30b6bfe 35 fields · synced May 30, 2026