FDA UDI
In Commercial Distribution
🇺🇸 United States
Bausch + Lomb
DI: 00757770056019
·
Model: MVS 1038A
·
Bausch & Lomb Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Bausch + Lomb
- Primary DI
- 00757770056019
- Version / Model
- MVS 1038A
- Catalog Number
- MVS 1038A
- Company Name
- Bausch & Lomb Incorporated
- Labeler DUNS
- 196603781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-11-08
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 511d0d75-7977-4bbd-ab07-39916f59fcaf
Device Description
Infusion Cannula
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46910 | Ophthalmic infusion cannula | A rigid tube designed to instill fluids [e.g., balanced salt solution (BSS), silicone oil] into the interior of the eye during ophthalmic surgery, typically to maintain the structural integrity of the eye after the procedure. It is typically made of high-grade stainless steel, and may include an attached length of flexible tubing made of plastic or silicone materials. It may be inserted directly through the sclera or the working channel of a pre-inserted cannula. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00757770056019 | GS1 | ||||
| Unit of Use | 10757770056016 | GS1 |