FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCUJECT injector Set 2.1-1P
DI: 07630055214584
·
Model: LP604590
·
Medicel AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACCUJECT injector Set 2.1-1P
- Primary DI
- 07630055214584
- Version / Model
- LP604590
- Catalog Number
- LP604590
- Company Name
- Medicel AG
- Labeler DUNS
- 487158263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-30
- Public Version
- 1
- Public Version Date
- 2025-10-08
- Public Version Status
- New
- Public Device Record Key
- d6c10022-ab68-43db-8c0b-7ef9160c93e7
Device Description
The ACCUJECT IOL injector is indicated to fold and insert BVI IOLs approved for use with this injector in the human eye.
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47725 | Manual intraocular lens injector, single-use | 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 plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630055214584 | GS1 |
Customer Contacts
- Phone
- +41717270969
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252540 | 000 |