FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Camino®
DI: 10381780040965
·
Model: FLEXEXT
·
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Camino®
- Primary DI
- 10381780040965
- Version / Model
- FLEXEXT
- Company Name
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Labeler DUNS
- 989925396
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-29
- Public Version
- 4
- Public Version Date
- 2020-04-06
- Public Version Status
- Update
- Public Device Record Key
- 018c63ef-4faf-4cd6-bb03-b56bf212a632
- Distribution End Date
- 2020-04-01
Device Description
The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Catheter to the Integra Camino ICP Monitor. It is an eight foot long silicone cable, with circular PEI (polyetherimide) connectors and a Ferrite clamp on suppressor.
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| GWM | DEVICE, MONITORING, INTRACRANIAL PRESSURE | Neurology | 882.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M273FLEXEXT1 | HIBCC | ||||
| Primary | 10381780040965 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121159 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8ft length |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature: -20°C (-4°F) to +50°C (+122°F). Relative Humidity, non-condensing: +25% to +80%. Keep dry.