Identity
- Trade Name
- Stradis Medical, LLC. FDA UDI
- Generic Name
- Wound dressing kit, non-medicated FDA UDI
- Device Name
- Dressing Change Tray FDA UDI
- Model / Reference
- DC352 FDA UDI
- Description
- Dressing Change Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- M752DC3520 FDA UDI
- FDA Product Code
- MCY FDA UDI
- GMDN Term
- Wound dressing kit, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5075 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Wound dressing kit, non-medicated
Stradis Medical, LLC. by Stradis Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound dressing kit, non-medicated.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Wound CareKit — Mirodx, LLC · Class II
- Susol® Ulcer Debridement Pack USA (Pack of 10) — BAILEY INSTRUMENTS LTD · Class II
- Susol® Wound Debridement Pack (Pack of 10) — BAILEY INSTRUMENTS LTD · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class I
- NuStat Flex — Beeken Biomedical · U
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
- Stradis Medical, Llc
Sources (1)
- FDA UDI e6a3fb1c-2426-4b5e-92e6-a441f2355824 34 fields · synced May 30, 2026