Identity
- Trade Name
- EZ-IO® TALON™ 38.5mm Manual Needle Set EUDAMEDARROW FDA UDI
- Generic Name
- Intraosseous infusion kit FDA UDI
- Device Name
- EZ-IO TALON NEEDLE SET EUDAMEDEZ-IO® TALON™ 38.5mm Manual Needle Set FDA UDI
- Model / Reference
- IPN033768 EUDAMEDFDA UDI9081-VC-006 EUDAMED
- Description
- EZ-IO® TALON™ 38.5mm Manual Needle Set FDA UDI
Identifiers
- Catalog Number
- 9081-VC-006 FDA UDI
- Primary DI / UDI-DI
- 10816000012489 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10816000012489 EUDAMED
- 510(k) Number
- K120661 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
- GMDN Term
- Intraosseous infusion kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Intraosseous infusion kit
Arrow by Teleflex Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K120661 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI e514d1ec-c70b-455a-8e6b-653038e0bcfc 36 fields · synced Jul 20, 2026
- EUDAMED 49b48176-da9e-46de-a95c-f4b2903883bb 61 fields · synced Jul 20, 2026