Identity
- Trade Name
- Neptune Plus Calcium Alginate Pad FDA UDI
- Generic Name
- Wound compression dressing FDA UDI
- Device Name
- Neptune Plus Calcium Alginate Pad FDA UDI
- Model / Reference
- 8870-03 FDA UDI
- Description
- Neptune Plus Calcium Alginate Pad FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331010497 FDA UDI
- 510(k) Number
- K040208 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound compression dressing 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
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: Wound compression dressing
Neptune Plus Calcium Alginate Pad by Tz Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound compression dressing.
- EAR DRESSING, ADULT — Oto-Med, Inc. · Class I
- InnovaMatrix PD — Triad Life Sciences, Inc. · U
- InnovaBurn — Triad Life Sciences, Inc. · U
- InnovaMatrix FS — Triad Life Sciences, Inc. · U
- HEAD & NECK PRESSURE DRESSING — Oto-Med, Inc. · Class I
- InnovaMatrix PD — Triad Life Sciences, Inc. · U
- OmniTrustTM — OMNI INTERNATIONAL CORP. · Class I
- InnovaBurn — Triad Life Sciences, Inc. · U
Cleared under the same submission
K040208 also covers:
- Biotronik Neptune — Tz Medical, Inc.
- E Neptune Hemostasis Pad — Tz Medical, Inc.
- Neptune — Tz Medical, Inc.
- Neptune Comfort Band — Tz Medical, Inc.
- Neptune Oval Pressure Disc — Tz Medical, Inc.
- Neptune ® Comfort Band with Calcium Alginate Wound Dressing — Tz Medical, Inc.
- Neptune ® Pressure Disc with Calcium Alginate Wound Dressing — Tz Medical, Inc.
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
- Tz Medical, Inc.
Sources (1)
- FDA UDI dce056eb-ac1b-4cde-8350-23ba1d62c75f 34 fields · synced Jun 8, 2026