FDA UDI
In Commercial Distribution
🇺🇸 United States
PHACOFIT
DI: 05050474520554
·
Model: OM05510114
·
JOHNSON & JOHNSON SURGICAL VISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PHACOFIT
- Primary DI
- 05050474520554
- Version / Model
- OM05510114
- Catalog Number
- OM05510114
- Company Name
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Labeler DUNS
- 103021940
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 4
- Public Version Date
- 2024-07-29
- Public Version Status
- Update
- Public Device Record Key
- 906b5689-240a-41d6-b6b3-280ab94f3fbc
Device Description
Inter-tip flush (5/bag)
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HMX | Cannula, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45149 | Ophthalmic surgical procedure kit, non-medicated, reusable | A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05050474520554 | GS1 |
Customer Contacts
- Phone
- +1(877)266-4543
- [email protected]