Identity
- Trade Name
- PENCAN® FDA UDI
- Generic Name
- Intrathecal anaesthesia set, non-medicated FDA UDI
- Device Name
- Pencan® 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) FDA UDI
- Model / Reference
- 333851 FDA UDI
- Description
- Pencan® 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) FDA UDI
Identifiers
- Catalog Number
- 333851 FDA UDI
- Primary DI / UDI-DI
- 04046964180606 FDA UDI
- FDA Product Code
- OFU FDA UDI
- GMDN Term
- Intrathecal anaesthesia set, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5120 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intrathecal anaesthesia set, non-medicated
Pencan® by B. Braun Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- B. Braun Medical Inc.
Sources (1)
- FDA UDI 1f0d3307-e30b-4ce6-a846-d41dd633a950 37 fields · synced May 30, 2026