Identity
- Trade Name
- Reach Needle FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Single use anesthesia needle FDA UDI
- Model / Reference
- CAT1614-05 FDA UDI
- Description
- Single use anesthesia needle FDA UDI
Identifiers
- Catalog Number
- CAT1614-05 FDA UDI
- Primary DI / UDI-DI
- 08886479300252 FDA UDI
- 510(k) Number
- K240253 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Hypodermic 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
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: Hypodermic needle, single-use
Reach Needle by Aerin Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Aerin Medical Inc.
Sources (1)
- FDA UDI c16bd9fb-69db-4e38-affe-31a432a9e531 36 fields · synced Jun 8, 2026