FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 10653160355052
·
Model: 8575FT3
·
CENTURION MEDICAL PRODUCTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Centurion
- Primary DI
- 10653160355052
- Version / Model
- 8575FT3
- Catalog Number
- 8575FT3
- Company Name
- CENTURION MEDICAL PRODUCTS CORPORATION
- Labeler DUNS
- 017246562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-02
- Public Version
- 1
- Public Version Date
- 2023-01-10
- Public Version Status
- New
- Public Device Record Key
- dd2c8073-a797-4ead-8570-6e98a5f2adfd
Device Description
ZM-02916 TOWEL,14X18,4.5IN DIA FEN,TAPE
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUI | Drape, surgical, exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47783 | Patient surgical drape, single-use | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00653160355055 | GS1 | CASE | 400 | In Commercial Distribution | |
| Primary | 10653160355052 | GS1 |
Customer Contacts
- Phone
- +1(517)546-5400
- [email protected]