FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Right Angle Guide
DI: 10381780034438
·
Model: 991002
·
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Right Angle Guide
- Primary DI
- 10381780034438
- Version / Model
- 991002
- Catalog Number
- 991002
- Company Name
- INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
- Labeler DUNS
- 531408342
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-01
- Public Version
- 4
- Public Version Date
- 2023-02-17
- Public Version Status
- Update
- Public Device Record Key
- cdae2687-1378-47f2-bb74-c2041d2d6f74
- Distribution End Date
- 2021-12-31
Device Description
The Right Angle Guide is a component of Integra NeuroSciences Hydrocephalus Valve Systems. It is used to form a right angle bend in a F7, F8 ventricular catheter at the burr hole (diameter 5 mm). Implanted materials are silicone elastomer impregnated with barium sulfate.
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61111 | Intracranial catheter holder | A small, sterile device designed to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may also be used as a marker for the planned depth of the catheter insertion. It typically has a gripping mechanism which creates a right angle bend in the tube, and is intended to be held in place with sutures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780034438 | GS1 | ||||
| Secondary | M2729910021 | HIBCC | ||||
| Package | 30381780034432 | GS1 | BOX | 5 | Not in Commercial Distribution | 2021-12-31 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K913842 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4.9mm Diam. |