FDA UDI
In Commercial Distribution
🇺🇸 United States
STERiJECT TM
DI: 04580708061504
·
Model: PRC-30013I
·
TSK LABORATORY, JAPAN
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2000
Basic Information
- Brand Name
- STERiJECT TM
- Primary DI
- 04580708061504
- Version / Model
- PRC-30013I
- Company Name
- TSK LABORATORY, JAPAN
- Labeler DUNS
- 716217877
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2021-12-22
- Public Version
- 1
- Public Version Date
- 2021-12-30
- Public Version Status
- New
- Public Device Record Key
- 329a818e-581a-4558-a828-5d1baf881ea0
Device Description
TSK STERiJECT Premium Disposable Hypodermic Needle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 | 14580708061501 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 04580708061504 | GS1 | ||||
| Package | 24580708061508 | GS1 | 1 | In Commercial Distribution | ||
| Unit of Use | 04571225315157 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970370 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.3 | Millimeter | |
| Length | 13 | Millimeter |