FDA UDI
In Commercial Distribution
🇺🇸 United States
EVA, combined machine including Laser (DORC connector)
DI: 08717872029993
·
Model: 8000.COM02
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EVA, combined machine including Laser (DORC connector)
- Primary DI
- 08717872029993
- Version / Model
- 8000.COM02
- Catalog Number
- 8000.COM02
- Company Name
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Labeler DUNS
- 407522184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-04
- Public Version
- 1
- Public Version Date
- 2019-10-14
- Public Version Status
- New
- Public Device Record Key
- e722b2a3-96d8-4baf-a48d-7fc9ea92102b
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
- No
- 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 |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Ophthalmic | 886.4150 | 2 |
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45072 | Phacoemulsification/vitrectomy system | An assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872029993 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190875 | 000 |