FDA UDI
In Commercial Distribution
🇺🇸 United States
Metier
DI: 06971564467261
·
Model: 1ml 25G*5/8"
·
Jiangsu Caina Medical Co.,Ltd
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Metier
- Primary DI
- 06971564467261
- Version / Model
- 1ml 25G*5/8"
- Catalog Number
- SSTBSTL0125058
- Company Name
- Jiangsu Caina Medical Co.,Ltd
- Labeler DUNS
- 544543513
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-26
- Public Version
- 2
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- ec063ca0-721c-4b84-823d-c857f5b51f2d
Device Description
The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
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
- No
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63096 | Tuberculin/allergy syringe/needle, basic | A sterile device consisting of a calibrated barrel (cylinder) with plunger, intended to be used to administer a precise, low-dosage injection of tuberculin and/or sensitivity test allergen to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16971564467268 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 06971564467261 | GS1 | ||||
| Package | 26971564467265 | GS1 | 8 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter | |
| Needle Gauge | 25 | Gauge | |
| Length | 0.625 | Inch |