FDA UDI
In Commercial Distribution
🇺🇸 United States
80542 Soft Step Anti Fatigue Mat - Light Green
DI: 00787551003048
·
Model: 80542
·
XODUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 80542 Soft Step Anti Fatigue Mat - Light Green
- Primary DI
- 00787551003048
- Version / Model
- 80542
- Catalog Number
- 80542
- Company Name
- XODUS MEDICAL, INC.
- Labeler DUNS
- 868042664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 2
- Public Version Date
- 2023-10-17
- Public Version Status
- Update
- Public Device Record Key
- 84517880-518b-4ea8-bd53-8efe4f60b9f9
Device Description
80542 Soft Step Anti Fatigue Mat - Light Green
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | FIBER, MEDICAL, ABSORBENT | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66117 | Absorbent underpad, non-antimicrobial, reusable | A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20787551003042 | GS1 | CASE | 6 | In Commercial Distribution | |
| Primary | 00787551003048 | GS1 |
Customer Contacts
- Phone
- +1(724)337-5500
- [email protected]