FDA UDI
In Commercial Distribution
🇺🇸 United States
Collection bag for Associate REF: 6279.ASD1 Cartridge.
DI: 08717872013459
·
Model: 6279.ASD4
·
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Collection bag for Associate REF: 6279.ASD1 Cartridge.
- Primary DI
- 08717872013459
- Version / Model
- 6279.ASD4
- Catalog Number
- 6279.ASD4
- 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
- 2023-09-14
- Public Version
- 1
- Public Version Date
- 2023-09-22
- Public Version Status
- New
- Public Device Record Key
- 20b6f712-ea32-47d1-b501-79b1c221b257
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | 886.4360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63972 | Ophthalmic surgery fluid collection bag | A non-sterile synthetic polymer bag intended to be used to collect aspirated materials (e.g., irrigation solution, vitreous humour, blood) from the eye during an ophthalmic surgical procedure, typically phacoemulsification/vitrectomy. It is connected to the surgical system drain port via tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 18717872013456 | GS1 | ||||
| Primary | 08717872013459 | GS1 |