FDA UDI
In Commercial Distribution
🇺🇸 United States
GBUK
DI: 06971911299156
·
Model: 1
·
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- GBUK
- Primary DI
- 06971911299156
- Version / Model
- 1
- Company Name
- Jiangsu Micsafe Medical Tehcnology Co.,LTD.
- Labeler DUNS
- 554400604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-20
- Public Version
- 1
- Public Version Date
- 2021-05-28
- Public Version Status
- New
- Public Device Record Key
- 4984e0af-cfb7-4dca-a9e4-069509361dad
Device Description
Safety Needle23G*1"
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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
| MEG | Syringe, Antistick | General Hospital | 880.5860 | 2 |
| FMF | Syringe, Piston | General Hospital | 880.5860 | 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 | 16971911299153 | GS1 | box | 100 | Not in Commercial Distribution | 2021-05-13 |
| Primary | 06971911299156 | GS1 | ||||
| Package | 26971911299150 | GS1 | case | 1600 | Not in Commercial Distribution | 2021-05-13 |