Identity
- Trade Name
- Temena FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- Pencil point spinal needle 25G x 35 mm without introducer FDA UDI
- Model / Reference
- 41950-25 FDA UDI
- Description
- Pencil point spinal needle 25G x 35 mm without introducer FDA UDI
Identifiers
- Catalog Number
- 41950-25 FDA UDI
- Primary DI / UDI-DI
- 03700339711765 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Spinal needle, single-use 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
No
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
Dimensions & Sizes
- Size
- Needle Gauge — 24 Gauge FDA UDILength — 35 Millimeter FDA UDI
Category: Spinal needle, single-use
Temena by Te ME NA Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal needle, single-use.
- Phoenix — DR.JAPAN CO., LTD. · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- Phoenix — DR.JAPAN CO., LTD. · Class II
- Standard Sprotte Needle — Pajunk GmbH Medizintechnologie · Class II
- LCCS — Lccs Products Limited · Class II
- Phoenix — DR.JAPAN CO., LTD. · Class II
- Phoenix — DR.JAPAN CO., LTD. · Class II
- Spinocan® — B. BRAUN MEDICAL INC. · Class II
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
- Te ME NA Sas
Sources (1)
- FDA UDI f9ba007b-51bc-437b-b83a-cea960472d43 35 fields · synced May 30, 2026