FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable I/A silicone replacement Tubing set for REF: 6279.ASD1 Cartridge, inc
DI: 08717872013435
·
Model: 6279.ASD2S
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- Disposable I/A silicone replacement Tubing set for REF: 6279.ASD1 Cartridge, inc
- Primary DI
- 08717872013435
- Version / Model
- 6279.ASD2S
- Catalog Number
- 6279.ASD2S
- 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
- 6
- 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
- 98a3207f-9f64-4adc-be09-6605a2c01c0e
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 |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45185 | Ultrasonic surgical system tubing set | A sterile collection of dual-lumen tubing and connectors that are used in an ultrasonic surgical system to transport irrigation fluid through one lumen to the surgical site, and remove the aspirate through the other for collection in a suction bottle/canister. The tubing connects to the system's generator at one end and will typically be fitted with safety connectors; it is used only with systems that include irrigation/aspiration. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717872013435 | GS1 | ||||
| Unit of Use | 18717872013432 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081877 | 000 |