Identity
- Trade Name
- MicronJet 600 FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.6 mm (600 micron) in length (height). This device can be mounted on any standard syringe (luer slip or luer lock connection) FDA UDI
- Model / Reference
- AS4018 FDA UDI
- Description
- A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.6 mm (600 micron) in length (height). This device can be mounted on any standard syringe (luer slip or luer lock connection) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290015928080 FDA UDI
- 510(k) Number
- K092746 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
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 — 600 Micrometer FDA UDI
Category: Hypodermic needle, single-use
MicronJet 600 by Nanopass Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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- EasyTouch — MHC Medical Products · Class II
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Cleared under the same submission
K092746 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
- Nanopass Technologies Ltd
Sources (1)
- FDA UDI 11be6d5c-d3a8-4da1-9977-8f9c6d56449b 37 fields · synced May 30, 2026