FDA UDI
In Commercial Distribution
🇺🇸 United States
MyVeo Headset
DI: 07630802403827
·
Model: 000000000010449164
·
Leica Microsystems (Schweiz) AG
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MyVeo Headset
- Primary DI
- 07630802403827
- Version / Model
- 000000000010449164
- Catalog Number
- 10449164
- Company Name
- Leica Microsystems (Schweiz) AG
- Labeler DUNS
- 480198725
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-02
- Public Version
- 2
- Public Version Date
- 2026-01-16
- Public Version Status
- Update
- Public Device Record Key
- efada1ad-4356-48ac-8cde-0aa7d9fd77cf
Device Description
MyVeo Headset - additional Headset to MyVeo Connection Hub
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| EPT | Microscope, surgical | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32036 | Headband, reusable | A device designed to be worn on the head of a healthcare provider for the mounting of another device, most commonly a head-worn light or a binocular indirect ophthalmoscope (BIO), so that the mounted device will remain directed in the user's line of vision despite head movement. It is typically adjustable for a custom fit. This is a reusable device. | No | Active |
| 36612 | Image display unit, colour | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630802403827 | GS1 |
Customer Contacts
- Phone
- +1(984)7105152
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify