FDA UDI
In Commercial Distribution
🇺🇸 United States
QUATTRO CASSETTE
DI: 04049539104526
·
Model: 303061-9015-000
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- QUATTRO CASSETTE
- Primary DI
- 04049539104526
- Version / Model
- 303061-9015-000
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-25
- Public Version
- 2
- Public Version Date
- 2024-01-31
- Public Version Status
- Update
- Public Device Record Key
- 5d86bddf-8d19-4814-acae-49ca47676872
Device Description
The Product is a single use sterile accessory kit for the ZEISS phaco and vitreoretinal systems and has been designed to direct balanced salt solution from irrigation source to the surgical handpieces and to convey the materials removed from the eye to a reservoir during eye surgery on anterior and posterior segments of the human eye.
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
- Yes
- 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 |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47625 | Surgical irrigation/aspiration tubing set | A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04049539104533 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 04049539104526 | GS1 |