Identity
- Trade Name
- Rocket FDA UDI
- Generic Name
- Fixed-diameter cervical dilator, reusable FDA UDI
- Device Name
- Rocket IPC DRessing Pack & Bag FDA UDI
- Model / Reference
- R51401-DP FDA UDI
- Description
- Rocket IPC DRessing Pack & Bag FDA UDI
Identifiers
- Catalog Number
- R51401-DP FDA UDI
- Primary DI / UDI-DI
- 05055270973429 FDA UDI
- 510(k) Number
- K123033 FDA UDI
- GMDN Term
- Fixed-diameter cervical dilator, reusable FDA UDI
Classification
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixed-diameter cervical dilator, reusable
Rocket by Rocket Medical Plc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-diameter cervical dilator, reusable.
- Surgical — TIMESCO HEALTHCARE LIMITED · Class I
- Hegar méhnyak tágító, enyhén kúpos heggyel, d= 3 mm, 180 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Kleegman Stainless Steel Dilator — MEDGYN PRODUCTS, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Galabins méhszonda, d= 3, 6 mm, 295 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · Class I
Cleared under the same submission
K123033 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Rocket Medical Plc
Sources (1)
- FDA UDI d76f1def-83ef-4d66-a5f7-f10a2f1ed68a 37 fields · synced Jun 8, 2026