Identity
- Trade Name
- Ceros FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Ceros Rigid Pack Standard Hypodermic Needle, 18 G x 1", Pink Polypropylene Hub, Latex Free, DEHP Free, PVC Free FDA UDI
- Model / Reference
- RM-RPSN511810 FDA UDI
- Description
- Ceros Rigid Pack Standard Hypodermic Needle, 18 G x 1", Pink Polypropylene Hub, Latex Free, DEHP Free, PVC Free FDA UDI
Identifiers
- Catalog Number
- RM-RPSN511810 FDA UDI
- Primary DI / UDI-DI
- 00850060997327 FDA UDI
- 510(k) Number
- K172938 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDILength — 1 Inch FDA UDI
Category: Hypodermic needle, single-use
Ceros by Rhino Medical Supply Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
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- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
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- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
Cleared under the same submission
K172938 also covers:
- Eclipse Hypodermic Needle - 18G — Eclipse, Inc.
- Eclipse Hypodermic Needle - 30G — Eclipse, Inc.
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Ceros — RHINO MEDICAL SUPPLY INC
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
- Rhino Medical Supply Inc
Sources (1)
- FDA UDI c6df81bf-7a98-4701-a3c4-46b682f5d4a5 37 fields · synced Jun 6, 2026