FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROLYZER
DI: 08681092003067
·
Model: CARTRIDGE
·
T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MICROLYZER
- Primary DI
- 08681092003067
- Version / Model
- CARTRIDGE
- Catalog Number
- MCR1
- Company Name
- T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI
- Labeler DUNS
- 505280884
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-14
- Public Version
- 1
- Public Version Date
- 2019-05-22
- Public Version Status
- New
- Public Device Record Key
- f1f80431-3532-4715-bc05-1197d7adf991
Device Description
Re-usable Microlyzer Cartridge to be used with Microlyzer Blade-Filter 2400, Microlyzer Blade-Filter 1200 and Microlyzer Blade-Filter 600.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJT | Aspiration Tray | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37447 | Aspiration tray, reusable | A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08681092003067 | GS1 |