FDA UDI
In Commercial Distribution
🇺🇸 United States
SurgiLux™
DI: M710SL120
·
Model: SL-12
·
BIOTEX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SurgiLux™
- Primary DI
- M710SL120
- Version / Model
- SL-12
- Catalog Number
- SL-12
- Company Name
- BIOTEX, INC.
- Labeler DUNS
- 969792050
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-01
- Public Version
- 2
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- c1ec1083-5af4-4543-8987-535d8dac1283
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FTD | Lamp, Surgical | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12282 | Operating room light | A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M710SL122 | HIBCC | Dispenser & 1-pack | 12 | In Commercial Distribution | |
| Primary | M710SL120 | HIBCC | ||||
| Package | M710SL124 | HIBCC | 4-pack | 48 | In Commercial Distribution |
Customer Contacts
- Phone
- 7137410111
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 25 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius