← Back to catalogue
Super Sheath 2.1 (nylon/Pebax) 3f - 5.5fsuper Sheath 2.1 (nylon/Pebax) 3f - 5.5f
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SUPER SHEATH 2.1 (NYLON/PEBAX) 3F - 5.5FSUPER SHEATH 2.1 (NYLON/PEBAX) 3F - 5.5F FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- 5.5F X 7CM TEARAWAY5.5F X 7CM TE INTRODUCER SET W/NITINOLINTRODUC GUIDEWIRE W/RADIOPAQUEGUIDEWIRE TIPTIP FDA UDI
- Model / Reference
- MR190507 FDA UDI
- Description
- 5.5F X 7CM TEARAWAY5.5F X 7CM TE INTRODUCER SET W/NITINOLINTRODUC GUIDEWIRE W/RADIOPAQUEGUIDEWIRE TIPTIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884908129137 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 2.1 (nylon/Pebax) 3f - 5.5fsuper Sheath 2.1 (nylon/Pebax) 3f - 5.5f 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Components Inc
Sources (1)
- FDA UDI 64bf5a6c-3a2a-4b7e-9561-c1b852ef0731 35 fields · synced May 30, 2026