FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270913937
·
Model: R57508
·
ROCKET MEDICAL PLC
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270913937
- Version / Model
- R57508
- Catalog Number
- R57508
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f1640f3b-b283-4197-a441-877ab050f9c5
Device Description
Rocket Cervical Mucus Sampling Syringe
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 32655 | Intrauterine cannula, single-use | A sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270935328 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 05055270913937 | GS1 | ||||
| Package | 05055270956729 | GS1 | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- +4401914196988
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20.0 | Centimeter | |
| Catheter Gauge | 6.0 | French |
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 Temperature
- Temperature Range
- -5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 30 Degrees Celsius