FDA UDI
In Commercial Distribution
🇺🇸 United States
RoboMarker G2
DI: B836RMSG2
·
Model: RMSG2
·
Surgilum, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RoboMarker G2
- Primary DI
- B836RMSG2
- Version / Model
- RMSG2
- Catalog Number
- RMSG2
- Company Name
- Surgilum, LLC
- Labeler DUNS
- 079726409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-02
- Public Version
- 1
- Public Version Date
- 2022-08-10
- Public Version Status
- New
- Public Device Record Key
- 5d667f33-77b0-4980-8b57-931847fe8209
Device Description
A manually-operated instrument intended to be used with a disposable handpiece tip (no included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-leveling mechanism intended to accept the ink-loaded tip; it include a battery powered fixation light intended to draw the patient's focus and a projected laser target to assist with accuracy during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 61740 | Corneal marker handpiece | A manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it may include a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B836RMSG2 | HIBCC |