FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumbar Catheter
DI: 10381780034247
·
Model: 951103
·
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lumbar Catheter
- Primary DI
- 10381780034247
- Version / Model
- 951103
- Catalog Number
- 951103
- Company Name
- INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
- Labeler DUNS
- 531408342
- Distribution Status
- 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
- a570bade-7b78-4023-b92e-355ead68a2a7
Device Description
The Integra Y- Lumbar Catheter consists of a F5 (ID: 0.8 mm) radiopaque silicone tubing with two open-ended arms (75 mm each) featuring several rows of inlet holes. The Y-shape consists of a 30 degree angle connection between the arms and the drainage catheter. The catheter overall length is 80 cm. A F5 radiopaque silicone Suture Clamp and a F8 -F5 radiopaque polypropylene Stepdown Connector (OD: 1.8 and 1.5 mm; ID: 0.8 mm) are supplied with the catheter.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 61525 | Lumboperitoneal shunt spinal catheter | A sterile implantable tube that is a component of a lumboperitoneal (LP) shunt intended to channel cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine in the management of elevated intracranial pressure due to increased CSF (hydrocephalus). It consists of a flexible tube fully implanted in the lumbar spine region and connected to a LP shunt valve. It is made of plastic materials and disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780034247 | GS1 | ||||
| Secondary | M2729511031 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K944595 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tubing 720mm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 2 Arms 75mm Length each, F8-F5 Stepdown Connector |