Identity
- Trade Name
- Coaxial Interventional Needle FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- This needle is intended for puncture and injection. FDA UDI
- Model / Reference
- KIM13/09T FDA UDI
- Description
- This needle is intended for puncture and injection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04262410680432 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 94 Millimeter FDA UDINeedle Gauge — 13 Gauge FDA UDI
Category: Hypodermic needle, single-use
Coaxial Interventional Needle by ITP Innovative Tomography Products GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ITP Innovative Tomography Products GmbH
Sources (2)
- FDA UDI 1bc09451-2e4f-42a8-a84c-c5f1114b8ca2 34 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026