FDA UDI
In Commercial Distribution
🇺🇸 United States
LightScalpel
DI: 00851842007388
·
Model: LS9001-01
·
Lightscalpel, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LightScalpel
- Primary DI
- 00851842007388
- Version / Model
- LS9001-01
- Catalog Number
- LS9001-01 Box
- Company Name
- Lightscalpel, LLC
- Labeler DUNS
- 033516010
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-17
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 9180e6a8-d4c6-495b-b694-656020d82f4a
Device Description
Tip, 0.8mm Spot, Non-Sterile
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36184 | Laser adaptor | A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851842007388 | GS1 |
Customer Contacts
- Phone
- 1-866-697-7548
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 19 | Millimeter | |
| Lumen/Inner Diameter | 0.8 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius