FDA UDI
In Commercial Distribution
🇺🇸 United States
KLARO In Vivo Surgical Lighting
DI: 08881300212001
·
Model: 555-01-01
·
VIVO SURGICAL PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- KLARO In Vivo Surgical Lighting
- Primary DI
- 08881300212001
- Version / Model
- 555-01-01
- Catalog Number
- 555-01-01
- Company Name
- VIVO SURGICAL PRIVATE LIMITED
- Labeler DUNS
- 659504181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-13
- Public Version
- 1
- Public Version Date
- 2023-03-21
- Public Version Status
- New
- Public Device Record Key
- 67aff76c-1ccd-4a78-92f4-c7cd35ae415b
Device Description
KLARO is a deep-cavity surgical LED lighting device for open surgery use. It is discreet, easy to use and provides bright, uniform and localised "flood-lighting" from within the surgical site. KLARO maintains a safe and cool working temperature suited for use inside the human body regardless of the luminous intensity selected.
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 |
|---|---|---|---|---|
| FTD | Lamp, Surgical | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65349 | Open surgical site internal light | An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08881300212018 | GS1 | Inner Box | 5 | In Commercial Distribution | |
| Primary | 08881300212001 | GS1 | ||||
| Package | 08881300212025 | GS1 | Shipper Box | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +6566770395
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 40 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius