FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AVENIO Millisect Head Assembly
DI: 07613336146620
·
Model: 08106550001
·
Roche Molecular Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AVENIO Millisect Head Assembly
- Primary DI
- 07613336146620
- Version / Model
- 08106550001
- Catalog Number
- 08106550001
- Company Name
- Roche Molecular Systems, Inc.
- Labeler DUNS
- 071674100
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 2
- Public Version Date
- 2020-11-27
- Public Version Status
- Update
- Public Device Record Key
- 736e6b67-4bf4-4a06-8a6b-7db461413a47
- Distribution End Date
- 2020-06-15
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 62866 | Slide-mounted-tissue dissection system IVD | An assembly of mains electricity (AC-powered) software-based devices designed to be used in the laboratory for the automated, or remotely-controlled, computer-aided dissection of microscope-slide-mounted tissue specimens under digital image guidance, allowing the user to digitally preselect the target dissection area with high precision. It consists of a high-resolution magnification unit, a robotic arm with an attached disposable milling tip, a remote control unit, and a display screen; excised tissues are suctioned into a sample tube for subsequent histopathology analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336146620 | GS1 |