FDA UDI
In Commercial Distribution
🇺🇸 United States
Licox®
DI: 10381780250111
·
Model: BC10R
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Licox®
- Primary DI
- 10381780250111
- Version / Model
- BC10R
- Catalog Number
- BC10R
- Company Name
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Labeler DUNS
- 989925396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-02
- Public Version
- 8
- Public Version Date
- 2023-05-12
- Public Version Status
- Update
- Public Device Record Key
- b034aa9d-df3c-4f3e-a8ef-ed80a96bd73e
Device Description
Licox® Probe test set
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| GWM | DEVICE, MONITORING, INTRACRANIAL PRESSURE | Neurology | 882.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36798 | Transistor tester | An electronic instrument designed to test the electrical performance of transistors and solid-state diodes to provide verification of their ability to function. It is typically used by biomedical service personnel involved in the repair, servicing, and maintenance of electrical medical devices. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780250111 | GS1 | ||||
| Previous | 10381780041245 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002765 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius