Identity
- Trade Name
- NuStat XR FDA UDI
- Generic Name
- Wound dressing kit, non-medicated FDA UDI
- Model / Reference
- XR-0408 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850392006162 FDA UDI
- 510(k) Number
- K183190 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound dressing kit, non-medicated FDA UDI
Classification
- Device Class
- U 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
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: Wound dressing kit, non-medicated
NuStat XR by Beeken Biomedical — Class U — 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
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC · Class II
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Stradis Medical, LLC — STRADIS MEDICAL, LLC · Class II
- Wound CareKit — Mirodx, LLC · Class II
- Susol® Ulcer Debridement Pack USA (Pack of 10) — BAILEY INSTRUMENTS LTD · Class II
Cleared under the same submission
K183190 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Beeken Biomedical
Sources (1)
- FDA UDI d1c20fc1-640e-455a-8c1a-5771da1f52a7 33 fields · synced Jun 1, 2026