FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270913722
·
Model: R57422-00-ST
·
ROCKET MEDICAL PLC
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270913722
- Version / Model
- R57422-00-ST
- Catalog Number
- R57422-00-ST
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 162f94d4-a4ab-491d-b021-0db1fe72aa50
Device Description
Rocket 5Fg HSG Sonohystogram Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18746 | Intrauterine imaging medium catheter | A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270935113 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 05055270913722 | GS1 | ||||
| Package | 05055270956514 | GS1 | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +4401914196988
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000340 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5.0 | French | |
| Length | 30.0 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 30 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity