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Generation Ii Valved Tearaway Introducergeneration Ii Valved Tearaway Introducer
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- GENERATION II VALVED TEARAWAY INTRODUCERGENERATION II VALVED TEARAWAY INTRODUCER FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- 15F VALVED PEELABLE INTRODUCER FDA UDI
- Model / Reference
- AAC15501 FDA UDI
- Description
- 15F VALVED PEELABLE INTRODUCER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884908000559 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Generation Ii Valved Tearaway Introducergeneration Ii Valved Tearaway Introducer by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID
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
- Medical Components Inc
Sources (1)
- FDA UDI 63bb39a7-4000-44ed-af89-42267f1c6a44 35 fields · synced Jun 1, 2026