FDA UDI
In Commercial Distribution
🇺🇸 United States
HEALON DUET PRO II
DI: 05050474755116
·
Model: 10300016
·
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
- HEALON DUET PRO II
- Primary DI
- 05050474755116
- Version / Model
- 10300016
- Catalog Number
- 10300016
- 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
- 2025-08-20
- Public Version
- 1
- Public Version Date
- 2025-08-28
- Public Version Status
- New
- Public Device Record Key
- c90ec084-3d41-4eb6-ab98-b9b6a373ac1a
Device Description
HEALON DUET PRO II US
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
- Yes
- 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 |
|---|---|---|---|---|
| LZP | AID, SURGICAL, VISCOELASTIC | Ophthalmic | 886.4275 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35907 | Vitreous/aqueous humour replacement medium, intraoperative | A nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05050474755116 | GS1 |
Customer Contacts
- Phone
- +1(877)266-4543
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT FREEZE
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT