Identity
- Trade Name
- SPiN Access Catheter, 180 Degree Catheter FDA UDI
- Generic Name
- Bronchoscopic catheter FDA UDI
- Model / Reference
- INS-5912 FDA UDI
Identifiers
- Catalog Number
- INS-5912 FDA UDI
- Primary DI / UDI-DI
- 00815686021283 FDA UDI
- 510(k) Number
- K170023 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Bronchoscopic catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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
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
Yes
FDA UDI
SPiN Access Catheter, 180 Degree Catheter by Veran Medical Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Veran Medical Technologies Inc.
Sources (1)
- FDA UDI 0fdda593-9d06-418d-8e46-2fa810d08a13 35 fields · synced May 30, 2026