Identity
- Trade Name
- MUC-X FDA UDI
- Generic Name
- ENT surgical aspirator FDA UDI
- Device Name
- MUC-X 10FR MUCOUS TRAP W/ WALL SUCTION ADAPTOR FDA UDI
- Model / Reference
- 10 French FDA UDI
- Description
- MUC-X 10FR MUCOUS TRAP W/ WALL SUCTION ADAPTOR FDA UDI
Identifiers
- Catalog Number
- IM71010FR FDA UDI
- Primary DI / UDI-DI
- H671IM71010FR0 FDA UDI
- 510(k) Number
- K893204 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- ENT surgical aspirator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 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
Category: ENT surgical aspirator
Muc-X by Utah Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT surgical aspirator.
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- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- JUHN TYM-TAP® — MEDTRONIC XOMED, INC. · Class I
- Surgical Aspirator Tip — Dynarex Corp. · Class I
- Surgical Aspirator Tip — Dynarex Corp. · Class I
- MUC-X — Utah Medical Products, Inc. · Class I
Cleared under the same submission
K893204 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 I | Pending data |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA UDI 78f6b7fc-f9d0-42f2-ae7e-22348c262b49 36 fields · synced Jun 9, 2026