FDA UDI
In Commercial Distribution
🇺🇸 United States
Medegen Medical Products, LLC
DI: 00700812000709
·
Model: 4091
·
MEDEGEN MEDICAL PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Medegen Medical Products, LLC
- Primary DI
- 00700812000709
- Version / Model
- 4091
- Company Name
- MEDEGEN MEDICAL PRODUCTS, LLC
- Labeler DUNS
- 055527753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-12-20
- Public Version
- 1
- Public Version Date
- 2020-12-28
- Public Version Status
- New
- Public Device Record Key
- a09b9274-0b68-4416-9bdf-c911894ad95f
Device Description
Syringe Piston 50/cs 56/plt
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) | General Hospital | 880.6960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35390 | Irrigation syringe | A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00700812000709 | GS1 | ||||
| Unit of Use | 10700812000706 | GS1 |