Identity
- Trade Name
- BD Eclipse, BD Luer-Lok FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- SYRINGE 5ML LL 23X1-1/2IN ECLIPSE RB TW FDA UDI
- Model / Reference
- 303307 FDA UDI
- Description
- SYRINGE 5ML LL 23X1-1/2IN ECLIPSE RB TW FDA UDI
Identifiers
- Catalog Number
- 303307 FDA UDI
- Primary DI / UDI-DI
- 00382903033072 FDA UDI
- 510(k) Number
- K161170 FDA UDI
- FDA Product Code
- FMI FDA UDIFMF FDA UDI
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 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
Yes
FDA UDI
Category: General-purpose syringe/needle
BD Eclipse, BD Luer-Lok by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe/needle.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
- CarePoint Precision — ALLISON MEDICAL, INC. · Class II
- YI XIN Sterile Syringe For Single Use — Jiang Xi Sanxin Medtec Co., Ltd. · Class II
- Micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD. · Class II
- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
- Azur Medical Company Inc. — Azur Medical Company, Inc. · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
Cleared under the same submission
K161170 also covers:
- BD Eclipse Needle — BECTON DICKINSON AND COMPANY
- BD Eclipse Needle 18G x 1 1/2 TW — BECTON DICKINSON AND COMPANY
- BD Eclipse Needle 25G x 1 1/2 TW — BECTON DICKINSON AND COMPANY
- BD Eclipse, BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD EclipseTM Needle 23G x 1"TW — BECTON DICKINSON AND COMPANY
- BD EclipseTM Needle 25G x 1"TW — BECTON DICKINSON AND COMPANY
- BD EclipseTM Needle 25G x 5/8"TW — BECTON DICKINSON AND COMPANY
- Eclipse — BECTON DICKINSON AND COMPANY
- Eclipse Needle — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI cc4b5f97-bdc9-48d2-bcfa-d41effeb2d24 35 fields · synced May 31, 2026