FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270983237
·
Model: R54549-26-PK
·
ROCKET MEDICAL PLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270983237
- Version / Model
- R54549-26-PK
- Catalog Number
- R54549-26-PK
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-23
- Public Version
- 2
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- 6c5b6d7c-3c46-4278-a47b-e835b636e2d8
Device Description
Rocket 26Fg Chest Catheter - Blunt Dissection Chest Drainage Insertion Pack
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62391 | Non-vascular catheter introduction set | A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055270983237 | GS1 | ||||
| Package | 05055270983251 | GS1 | Outer Carton | 5 | In Commercial Distribution |