FDA UDI
In Commercial Distribution
🇺🇸 United States
DELACROIX-CHEVALIER
DI: 03661219356615
·
Model: E229121
·
LANDANGER
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- DELACROIX-CHEVALIER
- Primary DI
- 03661219356615
- Version / Model
- E229121
- Company Name
- LANDANGER
- Labeler DUNS
- 299889175
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-09-23
- Public Version
- 1
- Public Version Date
- 2022-10-03
- Public Version Status
- New
- Public Device Record Key
- 60f12c66-66f8-4a73-aabb-921565c5eaa6
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63275 | Pleuroscopic/mediastinoscopic access cannula, single-use | A rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest to provide access to the pleural and/or mediastinal cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive procedure; it is not intended for pericardial access. It typically does not include an insufflation backflow valve and is not intended for endoscopic access requiring insufflation. It provides an entry between adjacent ribs and once in place is intended to remain in position for the duration of the procedure. It may include a trocar blade with a sharp or blunt tip designed to assist introduction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 03661219442141 | GS1 | ||||
| Primary | 03661219356615 | GS1 |