FDA UDI
In Commercial Distribution
🇺🇸 United States
AVID TruCustom
DI: 10809160209981
·
Model: VARV027-17_0001
·
AVID MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AVID TruCustom
- Primary DI
- 10809160209981
- Version / Model
- VARV027-17_0001
- Catalog Number
- VARV027-17
- Company Name
- AVID MEDICAL, INC.
- Labeler DUNS
- 015623119
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-19
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- d69dbda9-a6d1-4f6d-ba7f-194945402fa9
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJK | Eye tray | Ophthalmic | 886.4790 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57950 | Ophthalmic ultraviolet phototherapy system | A mains electricity (AC-powered) mobile device assembly, with a rechargeable battery, designed to deliver a uniform and metered dose of ultraviolet A (UVA) light to the cornea to perform an ophthalmic crosslinking procedure (collagen fibres in the cornea are linked together to stiffen the cornea). It is normally used in a clinical office setting and typically consists of a wheeled central mount that supports the optic head containing the UV source, user control panel, software, and a rechargeable battery. It is typically used to treat corneal disorders such as keratoconus, post laser assisted in situ keratomileusis (LASIK) ectasia, and other post-LASIK disorders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20809160209988 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 10809160209981 | GS1 |
Customer Contacts
- Phone
- +1(888) 564-7153
- [email protected]