FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 10653160385332
·
Model: MNS1320
·
CENTURION MEDICAL PRODUCTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Centurion
- Primary DI
- 10653160385332
- Version / Model
- MNS1320
- Catalog Number
- MNS1320
- Company Name
- CENTURION MEDICAL PRODUCTS CORPORATION
- Labeler DUNS
- 017246562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-23
- Public Version
- 1
- Public Version Date
- 2025-01-31
- Public Version Status
- New
- Public Device Record Key
- 69b7a536-6460-4e68-9956-9d1d0a20a506
Device Description
E.N.T. TRAY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LRO | General surgery tray | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44069 | ENT surgical procedure kit, non-medicated, single-use | A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00653160385335 | GS1 | CASE | 25 | In Commercial Distribution | |
| Primary | 10653160385332 | GS1 |
Customer Contacts
- Phone
- +1(517)546-5400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213481 | 000 |