FDA UDI
In Commercial Distribution
🇺🇸 United States
Surgilum
DI: B836TPS1010
·
Model: TPS101
·
Surgilum, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Surgilum
- Primary DI
- B836TPS1010
- Version / Model
- TPS101
- Catalog Number
- TPS101
- Company Name
- Surgilum, LLC
- Labeler DUNS
- 079726409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-12
- Public Version
- 2
- Public Version Date
- 2021-12-10
- Public Version Status
- Update
- Public Device Record Key
- 35910010-1980-46ab-977c-375db986d6e8
Device Description
A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a small device preloaded with ink. This is a single-use 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
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 | B836TPS1010 | HIBCC | ||||
| Package | B836TPS1012 | HIBCC | Box | 25 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Light Sensitive