FDA UDI
In Commercial Distribution
🇺🇸 United States
Ophthalmic trocar
DI: 03760087123876
·
Model: RETILOCK® 23G NON VALVED SELF-RETAINING TROCAR
·
FCI S A S FCI 20 22
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Ophthalmic trocar
- Primary DI
- 03760087123876
- Version / Model
- RETILOCK® 23G NON VALVED SELF-RETAINING TROCAR
- Catalog Number
- S9.7000.23
- Company Name
- FCI S A S FCI 20 22
- Labeler DUNS
- 763408366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-02-25
- Public Version
- 1
- Public Version Date
- 2020-03-04
- Public Version Status
- New
- Public Device Record Key
- 200a1898-43e5-45a2-9d87-ebdf65ad1043
Device Description
A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture the eye to provide access to the interior of the eye for ophthalmic surgery. It is assembled and used together with a compatible cannula, filling its lumen and providing the necessary sharp point, thereby facilitating the introduction of this assembly. The trocar is withdrawn after puncturing, providing a working channel into the interior of the eye. It is typically available for use with an ophthalmic cannulation set. This is a reusable device.
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47124 | Ophthalmic cannula transscleral trocar blade | A rigid, hand-held, manual ophthalmic surgical instrument with a sharp or blunt tip intended to fill the lumen of a compatible ophthalmic cannula (not included) and part eye tissue during cannula insertion into the eye (transscleral access). It is intended to be withdrawn once the cannula is in place. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 53760087123871 | GS1 | ||||
| Primary | 03760087123876 | GS1 |
Customer Contacts
- Phone
- 800-932-4202
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 23 | Gauge |