Identity
- Trade Name
- Foam Small EUDAMEDFDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Green Foam Thick Small EUDAMEDGenadyne 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-SFOAM2 EUDAMEDFDA 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
- 00849405031215 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405031215 EUDAMED
- 510(k) Number
- K092992 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Width — 10 Centimeter FDA UDILength — 7.5 Centimeter FDA UDIDepth — 3.3 Centimeter FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Foam Small 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.
- ALIVIOVISCO — LIDERMED S.A. · Class I
- Gamgee BP – Non-sterile 45x45cm — Robinson Healthcare Ltd · Class I
- 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.
- Foam Medium — 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 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 1e3af053-1440-46cc-9488-f7cec4f2dbc1 35 fields · synced Jul 10, 2026
- EUDAMED aacdbd3b-52b9-4535-8e2c-36ee8a4bed8e 61 fields · synced Jul 10, 2026