FDA UDI
In Commercial Distribution
🇺🇸 United States
Ceros
DI: 00850041572420
·
Model: RM-SN111815SB
·
Rhino Medical Supply Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ceros
- Primary DI
- 00850041572420
- Version / Model
- RM-SN111815SB
- Catalog Number
- RM-SN111815SB
- Company Name
- Rhino Medical Supply Inc
- Labeler DUNS
- 117524559
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-14
- Public Version
- 1
- Public Version Date
- 2024-03-22
- Public Version Status
- New
- Public Device Record Key
- cfd048d6-ad72-4659-9ef6-5b6932bc19de
Device Description
Ceros Standard Hypodermic Needle, 18 G x 1 1/2", Short Bevel, Pink Polypropylene Hub, Latex Free, DEHP Free, PVC Free
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59230 | Hypodermic needle, single-use | A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850041572427 | GS1 | Inner Box | 100 | In Commercial Distribution | |
| Primary | 00850041572420 | GS1 | ||||
| Package | 20850041572424 | GS1 | Shipper Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 833-997-4466
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172938 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 18 | Gauge | |
| Length | 1.5 | Inch |