FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270977144
·
Model: R57008-00-CN
·
ROCKET MEDICAL PLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270977144
- Version / Model
- R57008-00-CN
- Catalog Number
- R57008-00-CN
- 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
- 1
- Public Version Date
- 2023-11-01
- Public Version Status
- New
- Public Device Record Key
- bc145a51-acaf-44ad-ba76-8aeb378c99b8
Device Description
Copeland Fetal Scalp Electrode for Qwik Connect Cables
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
- Yes
- 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 |
|---|---|---|---|---|
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | Obstetrics/Gynecology | 884.2675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42560 | Foetal scalp electrode, clip | A sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a metallic clip electrode mounted on a small disk with a cable that may include a transducer. The clip is spring-loaded in a closed position until it is apposed on the foetal scalp, at which time the clip can be opened and released to a secure attachment. The electrode is typically used to monitor a foetal physiologic signal (e.g., heart rate) during labour (intrapartum) after rupture of the amniotic sac. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270977168 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 05055270977144 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K844608 | 000 |