Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- SureBlock(TM) Spinal Anesthesia Kit with 0.75% Bupivacaine and 8.25% Dextrose and Sharps Safety Features FDA UDI
- Model / Reference
- IPN045633 FDA UDI
- Description
- SureBlock(TM) Spinal Anesthesia Kit with 0.75% Bupivacaine and 8.25% Dextrose and Sharps Safety Features FDA UDI
Identifiers
- Catalog Number
- ASA-25090-SBS FDA UDI
- Primary DI / UDI-DI
- 40801902074261 FDA UDI
- 510(k) Number
- K911260 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
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
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
- Length — 9 Centimeter FDA UDI
Category: Spinal needle, single-use
Arrow by Teleflex Incorporated — 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
Cleared under the same submission
K911260 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI 58d99986-f188-4c7a-91de-265408c891ef 38 fields · synced Jun 8, 2026