Identity
- Trade Name
- Mepilex® Border Ag FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Device Name
- Mepilex Border Sacrum Ag, 23x23cm FDA UDI
- Model / Reference
- 382490 FDA UDI
- Description
- Mepilex Border Sacrum Ag, 23x23cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332551895198 FDA UDI
- 510(k) Number
- K100029 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound-nonadherent dressing, absorbent, antimicrobial
Mepilex® Border Ag by Mölnlycke Health Care AB — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, antimicrobial.
- Suprasorb P Sensitive Ag — L&R USA INC. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
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- ACTICOAT SURGIC 10X12CM 5PK US — Smith & Nephew Medical, Ltd. · U
- ALLEVYN AG ADHESIVE 7X7" CTN10 — Smith & Nephew Medical, Ltd. · U
- URGOCELL AG/SILVER — LABORATOIRES URGO · U
- Kendall — Cardinalhealth · U
- Exchange Select — Aafes · U
Cleared under the same submission
K100029 also covers:
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Ag — Mölnlycke Health Care AB
- Mepilex® Border Post-Op Ag — Mölnlycke Health Care AB
- Mepilex® Border Post-Op Ag — Mölnlycke Health Care AB
- Mepilex® Border Post-Op Ag — Mölnlycke Health Care AB
- Mepilex® Border Post-Op Ag — Mölnlycke Health Care AB
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 U | Pending data |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
Sources (1)
- FDA UDI 29fcf26d-3fe4-4e70-9127-8433f634bf60 36 fields · synced May 30, 2026