Identity
- Trade Name
- BD Eclipse™ Needle with SmartSlip™ Technology FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- NEEDLE ECLIPSE S/T 27X3/4 RB FDA UDI
- Model / Reference
- 305889 FDA UDI
- Description
- NEEDLE ECLIPSE S/T 27X3/4 RB FDA UDI
Identifiers
- Catalog Number
- 305889 FDA UDI
- Primary DI / UDI-DI
- 00382903058891 FDA UDI
- 510(k) Number
- K100209 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 — 0.75 Inch FDA UDINeedle Gauge — 27 Gauge FDA UDI
Category: Hypodermic needle, single-use
BD Eclipse™ Needle with SmartSlip™ Technology by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100209 also covers:
- BD Eclipse™ Needle with SmartSlip™ Technology — BECTON DICKINSON AND COMPANY
- BD Eclipse™ Needle with SmartSlip™ Technology — BECTON DICKINSON AND COMPANY
- BD Eclipse™ Needle with SmartSlip™ Technology — BECTON DICKINSON AND COMPANY
- BD Eclipse™ Needle with SmartSlip™ Technology — BECTON DICKINSON AND COMPANY
- BD Eclipse™ Needle with SmartSlip™ Technology — BECTON DICKINSON AND COMPANY
- BD Eclipse™ Needle with SmartSlip™ Technology — BECTON DICKINSON AND COMPANY
- BD Eclipse™ Needle with SmartSlip™ Technology — BECTON DICKINSON AND COMPANY
- Eclipse — BECTON DICKINSON AND COMPANY
- Eclipse — BECTON DICKINSON AND COMPANY
- Eclipse — BECTON DICKINSON AND COMPANY
- Eclipse — BECTON DICKINSON AND COMPANY
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
- Becton Dickinson And Company
Sources (1)
- FDA UDI 64aed605-f22f-4b08-986e-563664c26740 37 fields · synced May 30, 2026