FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 10653160275909
·
Model: FOAMPADST
·
CENTURION MEDICAL PRODUCTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Centurion
- Primary DI
- 10653160275909
- Version / Model
- FOAMPADST
- Catalog Number
- FOAMPADST
- Company Name
- CENTURION MEDICAL PRODUCTS CORPORATION
- Labeler DUNS
- 017246562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-01
- Public Version
- 1
- Public Version Date
- 2022-01-10
- Public Version Status
- New
- Public Device Record Key
- 986f0c60-ce58-4a15-9c5a-ce0c413f10bd
Device Description
STERILE FOAM PAD, FULL SIZE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FMP | Protector, skin pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58963 | Pressure-management bandage, padded | A non-sterile padded material designed to be worn over pressure-point areas of the body to help prevent the development of, and/or treat, pressure and friction sores in patients with restricted mobility in healthcare facilities. It is typically composed of a polyurethane foam layer bonded to a fabric layer (e.g., cotton, elastane, polyester) in the form of a tube intended to be worn on the limbs, or in the form of a flat sheet with fasteners intended to be worn around the pelvis to cover the sacral area. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00653160275902 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10653160275909 | GS1 |
Customer Contacts
- Phone
- +1(517)546-5400
- [email protected]