FDA UDI
In Commercial Distribution
🇺🇸 United States
RingJect
DI: 08717819070279
·
Model: 375US1G00
·
Ophtec B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RingJect
- Primary DI
- 08717819070279
- Version / Model
- 375US1G00
- Catalog Number
- 375US1G
- Company Name
- Ophtec B.V.
- Labeler DUNS
- 405048120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 5
- Public Version Date
- 2019-09-09
- Public Version Status
- Update
- Public Device Record Key
- 38fbbd73-9bfb-43f8-ab71-75cd23241ac5
Device Description
RingJect 12/10
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
- Yes
- 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 |
|---|---|---|---|---|
| MRJ | Ring, Endocapsular | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42839 | Capsular tension ring | A sterile, open-ended, non-optical circular band intended to be used to enhance the mechanical stability of a subluxated crystalline lens capsule in the presence of weak or absent supporting zonules. The device, commonly known as a capsular tension ring (CTR) or an endocapsular ring, is permanently implanted in the crystalline lens capsular bag during intraocular lens (IOL) surgery (e.g., cataract extraction) where it produces tension to distend the bag. It is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. Disposable devices associated with implantation (e.g., inserter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717819070279 | GS1 |
Customer Contacts
- Phone
- +31505251944
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030023 | 004 |
| P030023 | 005 |
| P030023 | 006 |
| P030023 | 007 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12.0 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 40 Degrees Celsius