Identity
- Trade Name
- Eclypse Border FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- Superabsorbent dressing with Silfix soft silicone contact layer and border 5in X 5in. Eclypse Border is an exudate management wound dressing. The dressing combines a Silfix soft silicone contact layer and border, a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate, a sub-backing layer for even exudate distribution and a non-strikethrough backing to prevent leakage. FDA UDI
- Model / Reference
- CR4523 FDA UDI
- Description
- Superabsorbent dressing with Silfix soft silicone contact layer and border 5in X 5in. Eclypse Border is an exudate management wound dressing. The dressing combines a Silfix soft silicone contact layer and border, a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate, a sub-backing layer for even exudate distribution and a non-strikethrough backing to prevent leakage. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031483444 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
Yes
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 — 5 Inch FDA UDILength — 5 Inch FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Eclypse Border by Brightwake Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial.
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- DUODERM — CONVATEC, PURCHASING DEPARTMENT · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brightwake Limited
Sources (2)
- FDA UDI fa41787d-674f-4d40-b5b0-f88d7d06b7c4 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026