FDA UDI
In Commercial Distribution
🇺🇸 United States
VitreQ
DI: 08719214222291
·
Model: LF00.R01
·
Vitreq B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VitreQ
- Primary DI
- 08719214222291
- Version / Model
- LF00.R01
- Company Name
- Vitreq B.V.
- Labeler DUNS
- 491393613
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-12
- Public Version
- 2
- Public Version Date
- 2022-09-28
- Public Version Status
- Update
- Public Device Record Key
- 3fc2a2a2-a543-4139-908e-0902fc6360ef
Device Description
Constellation® Light Source Adaptor
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37089 | Light source adaptor | A small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719214222291 | GS1 | ||||
| Direct Marking | 18719214222298 | GS1 |
Customer Contacts
- Phone
- 1.866.906.8080
- [email protected]