FDA UDI
In Commercial Distribution
🇺🇸 United States
Mesalt®
DI: 07323190293124
·
Model: 286080
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Mesalt®
- Primary DI
- 07323190293124
- Version / Model
- 286080
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-21
- Public Version
- 2
- Public Version Date
- 2022-11-23
- Public Version Status
- Update
- Public Device Record Key
- 4be8bcac-6123-4fcd-9bab-8ec2e6b1ef1c
Device Description
Mesalt 10x10cm
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
- Yes
- 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 |
|---|---|---|---|---|
| NAC | Dressing, wound, hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58475 | Sodium chloride dressing | A sterile material impregnated or saturated with sodium chloride (NaCl) or sodium chloride-based solutions (e.g., Ringer’s) intended to be applied to a skin wound to facilitate wound cleansing and healing by absorbing exudates and infectious/necrotic materials from the wound through osmotic action. It is available in various forms (e.g., non-woven material square/rectangle, ribbon) for application to superficial or deep wounds. It is normally used in a healthcare facility or in homecare. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07323190233212 | GS1 | CASE | 6 | In Commercial Distribution | |
| Package | 07323190233229 | GS1 | PACK_OR_INNER_PACK | 30 | In Commercial Distribution | |
| Primary | 07323190293124 | GS1 |
Customer Contacts
- Phone
- +46737733775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10cm x 10cm |