Identity
- Trade Name
- MicroDoc NPWT System FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, single-use FDA UDI
- Device Name
- MicroDoc NPWT Dressing, 10cm x 20cm (5cm x 15cm) FDA UDI
- Model / Reference
- 8463550 4012 FDA UDI
- Description
- MicroDoc NPWT Dressing, 10cm x 20cm (5cm x 15cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851978007559 FDA UDI
- 510(k) Number
- K200223 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, electric, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Negative-pressure wound therapy system, electric, single-use
MicroDoc NPWT System by Pensar Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200223 also covers:
- MicroDoc Mini Stingray and Drape Set — Pensar Medical, LLC
- MicroDoc NPWT Control Unit — Pensar Medical, LLC
- MicroDoc NPWT Control Unit — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
- MicroDoc NPWT System — Pensar Medical, LLC
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
- Pensar Medical, LLC
Sources (1)
- FDA UDI df7a518f-1881-439f-be78-6a4ce3485804 34 fields · synced Jun 6, 2026