FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270913623
·
Model: R57040
·
ROCKET MEDICAL PLC
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270913623
- Version / Model
- R57040
- Catalog Number
- R57040
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9fac60db-e167-40f1-9604-b27272a74c98
Device Description
Rocket Pudendal Block 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 |
|---|---|---|---|---|
| 34844 | Pudendal anaesthesia kit | A collection of sterile devices designed to deliver an analgesic or anaesthetic agent to the external genitalia of humans. It typically consists of a procedural needle, syringe, catheter, and a filter. It is typically used during labour, delivery, or both. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270956415 | GS1 | Box | 4 | In Commercial Distribution | |
| Package | 05055270935014 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 05055270913623 | 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
- Storage Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 30 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius