Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- 5 mL Arrow(R) Raulerson Spring-Wire Guide Introduction Syringe for use with .038", .035", .025" Spring-Wire Guide and Appropriate Introducer Needle FDA UDI
- Model / Reference
- IPN920470 FDA UDI
- Description
- 5 mL Arrow(R) Raulerson Spring-Wire Guide Introduction Syringe for use with .038", .035", .025" Spring-Wire Guide and Appropriate Introducer Needle FDA UDI
Identifiers
- Catalog Number
- AI-14703 FDA UDI
- Primary DI / UDI-DI
- 10801902195088 FDA UDI
- 510(k) Number
- K884490 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
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
Yes
FDA UDI
Category: General-purpose syringe, single-use
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K884490 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
- Teleflex Incorporated
Sources (1)
- FDA UDI e98860b9-64a9-41fb-baae-60e16d621b2a 36 fields · synced May 30, 2026