FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270913616
·
Model: R57032
·
ROCKET MEDICAL PLC
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270913616
- Version / Model
- R57032
- Catalog Number
- R57032
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-17
- Public Version
- 3
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- d0c2617a-5262-49a7-9a7a-61141e41605b
Device Description
Rocket CVS Chorionic Sampling Needle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 56709 | Chorionic villus sampling needle | A slender, sharply-pointed metal tube intended for transabdominal chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorionic villi for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. It is introduced transcutaneously into the uterus, possibly using a guide cannula and under ultrasonographic guidance, and may include connectors, tubing and aspiration 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 | 05055270956408 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 05055270913616 | GS1 |
Customer Contacts
- Phone
- +4401914196988
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.473 | Millimeter | |
| Length | 17.0 | Centimeter |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal