FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 10653160289111
·
Model: NSB25739B1
·
CENTURION MEDICAL PRODUCTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Centurion
- Primary DI
- 10653160289111
- Version / Model
- NSB25739B1
- Catalog Number
- NSB25739B1
- Company Name
- CENTURION MEDICAL PRODUCTS CORPORATION
- Labeler DUNS
- 017246562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-02
- Public Version
- 1
- Public Version Date
- 2022-01-10
- Public Version Status
- New
- Public Device Record Key
- 69c7f0fd-c637-4c01-b84b-8d5ef193eda5
Device Description
PEDIATRIC NASAL SPECULUM, NON STERILE
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 |
|---|---|---|---|---|
| EPY | SPECULUM, ENT | General, Plastic Surgery | 878.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42449 | Nasal speculum, single-use | A hand-held surgical instrument which is inserted into a nostril and manually expanded to open the nostril to a maximum by stretching the tissue around the nasal orifice allowing the doctor or surgeon access for examination or surgery during ear/nose/throat (ENT) intervention. It is made of disposable materials and has two blunt, contoured blades that are operated by the operator applying pressure to the pivoted handles or other mechanism. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00653160289114 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10653160289111 | GS1 |
Customer Contacts
- Phone
- +1(517)546-5400
- [email protected]