FDA UDI
In Commercial Distribution
🇺🇸 United States
Mepilex® Border Post-Op Ag
DI: 07333350972547
·
Model: 498450
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Mepilex® Border Post-Op Ag
- Primary DI
- 07333350972547
- Version / Model
- 498450
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-19
- Public Version
- 2
- Public Version Date
- 2024-12-16
- Public Version Status
- Update
- Public Device Record Key
- 7ce0d8ca-dadc-4c9f-a5f8-6e5658b79f08
Device Description
Mepilex Border Post-Op Ag 10x25cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, wound, drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47042 | Wound-nonadherent dressing, absorbent, antimicrobial | A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333350513627 | GS1 | PACK_OR_INNER_PACK | 5 | In Commercial Distribution | |
| Primary | 07333350972547 | GS1 | ||||
| Package | 07333350710361 | GS1 | CASE | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +46737733775
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100029 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10cm x 25cm |