Identity
- Trade Name
- XLR8 Transparent Film Dressing FDA UDI
- Generic Name
- Negative-pressure wound therapy system drape FDA UDI
- Device Name
- Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm. FDA UDI
- Model / Reference
- A4-S00F5 FDA UDI
- Description
- Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm. FDA UDI
Identifiers
- Catalog Number
- A4-S00F5 FDA UDI
- Primary DI / UDI-DI
- 00849405000013 FDA UDI
- 510(k) Number
- K143726 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system drape 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 drape
XLR8 Transparent Film Dressing by Genadyne Biotechnologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system drape.
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Cleared under the same submission
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 3805b7f4-0edf-4358-8d09-74d151ac207d 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026