FDA UDI
In Commercial Distribution
🇺🇸 United States
TrabEx Pro
DI: 00844685009381
·
Model: 600050-01
·
MICROSURGICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TrabEx Pro
- Primary DI
- 00844685009381
- Version / Model
- 600050-01
- Catalog Number
- 600050-01
- Company Name
- MICROSURGICAL TECHNOLOGY, INC.
- Labeler DUNS
- 097824130
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-22
- Public Version
- 4
- Public Version Date
- 2023-11-01
- Public Version Status
- Update
- Public Device Record Key
- 2ba175b4-c8b4-450a-be0a-40eb78eafabe
Device Description
The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
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
- 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 |
|---|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46741 | Ophthalmic knife, single-use | A hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844685009381 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213173 | 000 |