Identity
- Trade Name
- Rocket FDA UDI
- Generic Name
- Foetal scalp electrode, clip FDA UDI
- Model / Reference
- R57008-00-FM FDA UDI
Identifiers
- Catalog Number
- R57008-00-FM FDA UDI
- Primary DI / UDI-DI
- 05055270977113 FDA UDI
- 510(k) Number
- K844608 FDA UDI
- FDA Product Code
- HGP FDA UDI
- GMDN Term
- Foetal scalp electrode, clip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foetal scalp electrode, clip
Rocket by Rocket Medical Plc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal scalp electrode, clip.
- Rocket — Rocket Medical Plc · Class II
Cleared under the same submission
K844608 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rocket Medical Plc
Sources (1)
- FDA UDI e6037a26-6a82-4bfe-a3b2-03172fb9b995 34 fields · synced May 31, 2026