FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270988546
·
Model: R57525-00-ME
·
ROCKET MEDICAL PLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270988546
- Version / Model
- R57525-00-ME
- Catalog Number
- R57525-00-ME
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-24
- Public Version
- 2
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 01329d36-569c-4dac-8e01-850bf9cfaa06
Device Description
Needle Guide
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
- 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 |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45018 | Needle guide, single-use | A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270988553 | GS1 | Inner Carton | 10 | In Commercial Distribution | |
| Primary | 05055270988546 | GS1 | ||||
| Package | 05055270988560 | GS1 | Outer Carton | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032015 | 000 |