Identity
- Trade Name
- Medcomp Micro-Stick Introducer Sets EUDAMEDMICRO-STICK®SET FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- Medcomp/Jet Micro-Stick Introducer Sets EUDAMED4F (1.0MM ID) X 9CM REGULAR MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP AND 4CM NEEDLE FDA UDI
- Model / Reference
- MR193421 EUDAMEDFDA UDI
- Description
- 4F (1.0MM ID) X 9CM REGULAR MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP AND 4CM NEEDLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884908169478 EUDAMED00884908090505 FDA UDI
- Basic UDI-DI
- 00884908311MV EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0501 CARDIOVASCULAR INTRODUCER SHEATHS, NON-VALVED EUDAMED
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Micro-Stick®set by Medical Components Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medical Components Inc
Sources (2)
- FDA UDI 94c17fae-e199-4d44-b95d-394d48546d09 35 fields · synced Jun 14, 2026
- EUDAMED 790c0a9d-fe83-49f8-bd63-15a5ccfaa3eb 61 fields · synced Jun 14, 2026