FDA UDI
Not in Commercial Distribution
🇺🇸 United States
WHITESTAR PHACO HANDPIECE
DI: 05050474508064
·
Model: 690699
·
JOHNSON & JOHNSON SURGICAL VISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WHITESTAR PHACO HANDPIECE
- Primary DI
- 05050474508064
- Version / Model
- 690699
- Catalog Number
- 690699
- Company Name
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Labeler DUNS
- 103021940
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 5
- Public Version Date
- 2023-06-06
- Public Version Status
- Update
- Public Device Record Key
- b4e830b6-bc86-451b-9439-54c0c9e09cfd
- Distribution End Date
- 2018-09-19
Device Description
WHITESTAR SILICONE IRRIGATION TUBING 6PK
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
- 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 |
|---|---|---|---|---|
| KYG | DEVICE, IRRIGATION, OCULAR SURGERY | Ophthalmic | 886.4360 | 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 | 05050474508064 | GS1 | ||||
| Package | 15050474508061 | GS1 | BOX | 6 | Not in Commercial Distribution | 2018-09-19 |
Customer Contacts
- Phone
- +1(877)266-4543
- [email protected]