FDA UDI
In Commercial Distribution
🇺🇸 United States
RoboTip G2
DI: B836TPSG2
·
Model: TPSG2
·
Surgilum, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RoboTip G2
- Primary DI
- B836TPSG2
- Version / Model
- TPSG2
- Catalog Number
- TPSG2
- Company Name
- Surgilum, LLC
- Labeler DUNS
- 079726409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-08
- Public Version
- 1
- Public Version Date
- 2022-08-16
- Public Version Status
- New
- Public Device Record Key
- dde95e38-5d7a-42c2-bd06-8c804d2c3f49
Device Description
A sterile device intended to be fitted to the RoboMarker G2 (Corneal Marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. This is a single-use, sterile device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HMR | Marker, Ocular | Ophthalmic | 886.4570 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61739 | Corneal marker handpiece tip | A sterile device intended to be fitted to a corneal marker handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure. It is typically a small device preloaded with ink. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B836TPSG2 | HIBCC |