FDA UDI
In Commercial Distribution
🇺🇸 United States
Illuminated infusion cannula, 1.2 mm.
DI: 08717872009421
·
Model: 3269.D1D
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Illuminated infusion cannula, 1.2 mm.
- Primary DI
- 08717872009421
- Version / Model
- 3269.D1D
- Catalog Number
- 3269.D1D
- 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
- 5
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- e17f5945-cc29-483d-accb-1098b1e28ce8
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42572 | Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use | A hand-held ophthalmic surgical instrument with a thin, rigid insertion portion designed to infuse, irrigate and/or aspirate the interior of the eye during a surgical procedure (e.g., cataract extraction), and simultaneously conduct, typically via a fibreoptic bundle, a field of cold light to illuminate the surgical site. It is connected to a light source (through a light cable) and to appropriate devices that provide the infusion/aspiration function. It is typically made of high-grade stainless steel and fibreoptic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872009421 | GS1 | ||||
| Unit of Use | 18717872009428 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062895 | 000 |