Identity
- Trade Name
- BD Perisafe™ FDA UDI
- Generic Name
- Epidural needle, non-threaded FDA UDI
- Device Name
- NEEDLE EPID S/SU 18GA TW 3-1/2IN TUOHY FDA UDI
- Model / Reference
- 405018 FDA UDI
- Description
- NEEDLE EPID S/SU 18GA TW 3-1/2IN TUOHY FDA UDI
Identifiers
- Catalog Number
- 405018 FDA UDI
- Primary DI / UDI-DI
- 00382904050184 FDA UDI
- 510(k) Number
- K211085 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Epidural needle, non-threaded FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 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
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
No
FDA UDI
Category: Epidural needle, non-threaded
BD Perisafe™ by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epidural needle, non-threaded.
- Entrada ™ — Boston Scientific Neuromodulation · Class III
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
- Halyard — AVID MEDICAL, INC. · Class II
- TUOHY — Pajunk GmbH Medizintechnologie · Class II
- TuohySono — Pajunk GmbH Medizintechnologie · Class II
- Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
- LCCS — Lccs Products Limited · Class II
Cleared under the same submission
K211085 also covers:
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
- Becton Dickinson And Company
Sources (1)
- FDA UDI eb0d548d-0251-40dc-8183-f7009bb7e15d 35 fields · synced May 30, 2026