FDA UDI
In Commercial Distribution
🇺🇸 United States
Z Cartridge IOL Delivery System - Handpiece
DI: 00843045101840
·
Model: R28
·
CARL ZEISS MEDITEC PRODUCTION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Z Cartridge IOL Delivery System - Handpiece
- Primary DI
- 00843045101840
- Version / Model
- R28
- Catalog Number
- 003500-0047-252
- Company Name
- CARL ZEISS MEDITEC PRODUCTION, LLC
- Labeler DUNS
- 080685425
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-07
- Public Version
- 3
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- d09c7745-bf0f-4916-bacb-083828b52264
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47724 | Manual intraocular lens injector, reusable | A hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of lightweight metal materials [e.g., titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843045101840 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123888 | 000 |