FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Licox®
DI: 10381780041252
·
Model: BC10S
·
GMS, Gesellschaft für medizinische Sondentechnik mbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Licox®
- Primary DI
- 10381780041252
- Version / Model
- BC10S
- Catalog Number
- BC10S
- Company Name
- GMS, Gesellschaft für medizinische Sondentechnik mbH
- Labeler DUNS
- 315902197
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3dd74cd7-39e9-4941-b594-2ac9fd0fce22
- Distribution End Date
- 2016-08-02
Device Description
Licox® CMP Adaptor for patient safety test
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
- 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
- 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 |
|---|---|---|---|---|
| 37946 | Leakage current tester | A battery-powered instrument intended to be used to perform either alternating current (AC) or direct current (DC) leakage testing on electronic equipment. It typically includes an Amperimeter that can measure in a range of milliamperes/amperes and appropriate accessories (e.g., leads, clips) to perform the measurements. The device may determine leakage current in medical device chassis and patient leads, preventing patient risks (e.g., heart fibrillation). Some devices include visual and/or sound alarms that operate when a pre-set value is reached. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M273BC10S0 | HIBCC | ||||
| Primary | 10381780041252 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002765 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 250 mm x 180 mm |