FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04961333241194
·
Model: 82447
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- N/A
- Primary DI
- 04961333241194
- Version / Model
- 82447
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-03-13
- Public Version
- 1
- Public Version Date
- 2018-04-13
- Public Version Status
- New
- Public Device Record Key
- e6cc3c63-9021-47ec-b477-dfc567c64b3f
Device Description
ENDOBRONCHIAL TBNA NEEDLE 22GA 4.0L 5PC
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44921 | Flexible ultrasound bronchoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the trachea, bronchi, and lungs. It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by the device typically through a fibreoptic bundle or a video system, and an ultrasound probe. The probe may be built-in or inserted through a dedicated lumen so that its distal tip is positioned adjacent to that of the endoscope. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333241194 | GS1 | ||||
| Unit of Use | 14961333241191 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 22.0 | Gauge | |
| Total Volume | 4.0 | Liter |