FDA UDI
In Commercial Distribution
🇺🇸 United States
Phaco needle, 30°, flared Ø 1.2 mm with blue REF: 3003 sleeve, inner Ø 0.6 mm
DI: 08717872009216
·
Model: 3006.PF630
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Phaco needle, 30°, flared Ø 1.2 mm with blue REF: 3003 sleeve, inner Ø 0.6 mm
- Primary DI
- 08717872009216
- Version / Model
- 3006.PF630
- Catalog Number
- 3006.PF630
- 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
- 3
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2019-02-15
- Public Version Status
- Update
- Public Device Record Key
- 8f33be42-c4d9-49c4-b397-8fb9e0f7bd9e
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34900 | Phacoemulsification system handpiece | A holder for a dedicated detachable tip that together become a unit that delivers energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). This device will be activated by the surgeon using a foot control and may provide or facilitate the irrigation/suction systems needed for the removal of debris. The handpiece typically designed in the form of a pen or pencil. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872009216 | GS1 | ||||
| Unit of Use | 18717872009213 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081877 | 000 |