FDA UDI
In Commercial Distribution
🇺🇸 United States
Bausch + Lomb
DI: 10757770507600
·
Model: BL5290ASP
·
Bausch & Lomb Incorporated
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Bausch + Lomb
- Primary DI
- 10757770507600
- Version / Model
- BL5290ASP
- Catalog Number
- BL5290ASP
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ea8c3fa7-1baa-4a03-8b52-b1f1779d26a5
Device Description
20G ST ASP L PROBE 5/BOX
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 |
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61162 | Ophthalmic laser system beam guide | A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10757770507600 | GS1 | ||||
| Unit of Use | 00757770507603 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061024 | 000 |