FDA UDI
In Commercial Distribution
🇺🇸 United States
Elset®
DI: 05055158001503
·
Model: 3482
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Elset®
- Primary DI
- 05055158001503
- Version / Model
- 3482
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-01
- Public Version
- 1
- Public Version Date
- 2023-11-09
- Public Version Status
- New
- Public Device Record Key
- 57985e18-59fe-4928-b46f-86679fde3de4
Device Description
Elset 10cm x 6m x 12
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | BANDAGE, ELASTIC | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63279 | Pressure bandage, Hevea-latex, reusable | A strip or roll made of fabric which includes Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema), and may in addition be intended for dressing retention. The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07332551976958 | GS1 | CASE | 5 | In Commercial Distribution | |
| Package | 05055158001831 | GS1 | PACK_OR_INNER_PACK | 12 | In Commercial Distribution | |
| Primary | 05055158001503 | GS1 |
Customer Contacts
- Phone
- +46737733775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6m |