Identity
- Trade Name
- Foam Medium FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Genadyne Green Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device. FDA UDI
- Model / Reference
- XF-MFOAM2 FDA UDI
- Description
- Genadyne Green Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405031222 FDA UDI
- 510(k) Number
- K092992 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial 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
Dimensions & Sizes
- Size
- Depth — 3.3 Centimeter FDA UDILength — 12.5 Centimeter FDA UDIWidth — 18 Centimeter FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Foam Medium by Genadyne Biotechnologies Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
Cleared under the same submission
K092992 also covers:
- Foam Kit Small — GENADYNE BIOTECHNOLOGIES INC.
- Foam Kit Thin X-Large — GENADYNE BIOTECHNOLOGIES INC.
- Bridge Dressing — GENADYNE BIOTECHNOLOGIES, INC.
- Bridge Dressing Kit — GENADYNE BIOTECHNOLOGIES, INC.
- Foam Kit Large — GENADYNE BIOTECHNOLOGIES, INC.
- Foam Kit Medium — GENADYNE BIOTECHNOLOGIES, INC.
- Foam Kit Thin Large — GENADYNE BIOTECHNOLOGIES, INC.
- Foam Kit Thin Medium — GENADYNE BIOTECHNOLOGIES, INC.
- Foam Kit Thin Small — GENADYNE BIOTECHNOLOGIES, INC.
- Foam Large — GENADYNE BIOTECHNOLOGIES, INC.
- Foam Small — GENADYNE BIOTECHNOLOGIES, INC.
- Foam T Medium — GENADYNE BIOTECHNOLOGIES, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies Inc.
Sources (2)
- FDA UDI 8a334ecf-fcb1-414f-9bfe-373f9ac1de30 35 fields · synced Jun 11, 2026
- EUDAMED 1 fields · synced Jun 11, 2026