Identity
- Trade Name
- SUPER SHEATH 2.0SUPER SHEATH 2.0 FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- 6.5F (2.0MM ID) X 10CM6.5F (2.0M TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP FDA UDI
- Model / Reference
- DMR190610 FDA UDI
- Description
- 6.5F (2.0MM ID) X 10CM6.5F (2.0M TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP FDA UDI
Identifiers
- Catalog Number
- DMR190610 FDA UDI
- Primary DI / UDI-DI
- 00884908144642 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
Super Sheath 2.0super Sheath 2.0 by Medical Components 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
- Medical Components Inc
Sources (1)
- FDA UDI bdb54df3-33d5-4540-8a4c-6e9956fc0048 36 fields · synced May 30, 2026