FDA UDI
In Commercial Distribution
🇺🇸 United States
Lazurite Holdings LLC ArthroFree Sterilization Tray Kit
DI: 00860001744293
·
Model: AF0030-101-10
·
Lazurite Holdings LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lazurite Holdings LLC ArthroFree Sterilization Tray Kit
- Primary DI
- 00860001744293
- Version / Model
- AF0030-101-10
- Company Name
- Lazurite Holdings LLC
- Labeler DUNS
- 088448366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 1
- Public Version Date
- 2022-09-22
- Public Version Status
- New
- Public Device Record Key
- 18ea6567-6bbe-42e3-aa67-40aadf8e9139
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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
- Yes
- Sterilization Methods
- Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60490 | Video camera surgical microscope system | An assembly of noninvasive devices intended to transmit detailed, magnified, video images from a surgical site (non-specific) to a monitor to facilitate visualization of the surgical site by the surgeon; it may include recording equipment for teaching applications. It typically includes a fibreoptic telescope, illumination hardware, video camera, positioning arm, appropriate hardware/cabling, and may include recording unit, monitor and transportation cart. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001744293 | GS1 |
Customer Contacts
- Phone
- +1(833)214-2324
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Long Term Storage, between 30 and 75 percent Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Long Term Storage, between -20 and 20 degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Short Storage and Transport, Between -20 and 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Short Storage and Transport, between 10 and 75 percent relative humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Short Storage and Transport, between 50 and 106 Kilopascal
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Long Term Storage, between 70 and 106 Kilopascal