FDA UDI
In Commercial Distribution
🇺🇸 United States
Bausch + Lomb
DI: 00757770059379
·
Model: BL3394
·
Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Bausch + Lomb
- Primary DI
- 00757770059379
- Version / Model
- BL3394
- Catalog Number
- BL3394
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-11-04
- Public Version
- 5
- Public Version Date
- 2018-10-29
- Public Version Status
- Update
- Public Device Record Key
- d1fff485-a4f3-4758-bd7f-a39e3d251fc1
Device Description
Vit Handle Extension
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 |
|---|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Ophthalmic | 886.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47130 | Vitrectomy fluid/gas handling handpiece/cannula | A sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00757770059379 | GS1 | ||||
| Unit of Use | 10757770059376 | GS1 |