Identity
- Trade Name
- Spiro Foam Dressing Kit FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- The Genadyne Spiro Foam Dressing Kit consists of a XLR8 Port, two XLR8 Transparent Film and a two Spiro Foam Dressing. Each component is packaged, sealed and sterilized individually and then bagged into a kit. FDA UDI
- Model / Reference
- XF-SPMK1 FDA UDI
- Description
- The Genadyne Spiro Foam Dressing Kit consists of a XLR8 Port, two XLR8 Transparent Film and a two Spiro Foam Dressing. Each component is packaged, sealed and sterilized individually and then bagged into a kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405021322 FDA UDI
- 510(k) Number
- K141961 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
No
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
Yes
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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Spiro Foam Dressing Kit by Genadyne Biotechnologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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Cleared under the same submission
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
- Genadyne Biotechnologies, Inc.
Sources (1)
- FDA UDI dc24f8e4-e1e3-4732-9fe9-7fff743da93d 34 fields · synced Jun 4, 2026