FDA UDI
In Commercial Distribution
🇺🇸 United States
Gongdong
DI: 06947462492247
·
Model: E1030
·
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
9600
Basic Information
- Brand Name
- Gongdong
- Primary DI
- 06947462492247
- Version / Model
- E1030
- Company Name
- ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
- Labeler DUNS
- 529309049
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9600
- Record Status
- Published
- Publish Date
- 2022-08-04
- Public Version
- 1
- Public Version Date
- 2022-08-12
- Public Version Status
- New
- Public Device Record Key
- eff8fb04-33b0-4395-b63e-40a2b67fd84d
Device Description
Pipette Tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16822 | Pipette tip | A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette or a dispenser and where the required volume of liquid is drawn for delivery to the target receptacle. It may show a gradient scale or not and is usually made of plastic but may also be made of glass. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 86947462492243 | GS1 | ||||
| Primary | 06947462492247 | GS1 |