Identity
- Trade Name
- Rocket FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Needle Guide FDA UDI
- Model / Reference
- R57525-00-ME FDA UDI
- Description
- Needle Guide FDA UDI
Identifiers
- Catalog Number
- R57525-00-ME FDA UDI
- Primary DI / UDI-DI
- 05055270988546 FDA UDI
- 510(k) Number
- K032015 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
No
FDA UDI
Category: Needle guide, single-use
Rocket by Rocket Medical Plc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
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Cleared under the same submission
K032015 also covers:
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
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 01329d36-569c-4dac-8e01-850bf9cfaa06 35 fields · synced Jun 1, 2026