Identity
- Trade Name
- MIller Advance Catheter FDA UDI
- Generic Name
- Intrauterine imaging medium catheter FDA UDI
- Device Name
- Balloon catheter with an insertion sheath for hysterosalpingography and saline infusion sonohysterography FDA UDI
- Model / Reference
- 5F HS Catheter FDA UDI
- Description
- Balloon catheter with an insertion sheath for hysterosalpingography and saline infusion sonohysterography FDA UDI
Identifiers
- Catalog Number
- TMI2001 FDA UDI
- Primary DI / UDI-DI
- 00852073002210 FDA UDI
- 510(k) Number
- K123258 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Intrauterine imaging medium catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
Yes
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
Dimensions & Sizes
- Size
- Length — 25 Centimeter FDA UDICatheter Gauge — 5 French FDA UDI
Category: Intrauterine imaging medium catheter
MIller Advance Catheter by C R I — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intrauterine imaging medium catheter.
- Cook — COOK INCORPORATED · Class II
- uVue — COOK INCORPORATED · Class II
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc
- Rocket — Rocket Medical Plc · Class II
- Batrik H/S Catheter TM 5F — Batrik Medical Manufacturing Inc · Class II
- Rocket — Rocket Medical Plc
- Cook — COOK INCORPORATED · Class I
Cleared under the same submission
K123258 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 |
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Manufacturer
- Manufacturer
- C R I
Sources (1)
- FDA UDI 72142c3a-75f8-4caf-a8ec-a48c83c10dec 38 fields · synced Jun 6, 2026