FDA UDI
In Commercial Distribution
🇺🇸 United States
Peritoneal Catheter
DI: 10381780037224
·
Model: PC1
·
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Peritoneal Catheter
- Primary DI
- 10381780037224
- Version / Model
- PC1
- Catalog Number
- PC1
- 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
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- ce5155f7-b5bd-4da3-b6a5-8a20e5f8711d
Device Description
The Integra NeuroSciences Peritoneal Catheter is a 91 cm silicone elastomer barium sulfate striped tubing. Numbered length markers are located 5, 10, 15, 20, 25 and 30 cm from the distal end to assist catheter placement. The distal end of the catheter has four staggered rows of 5.5-mm slits, which are not easily visible. If the distal outlet hole of the catheter becomes obstructed, the slits open for drainage.
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 |
|---|---|---|---|---|
| 61159 | Peritoneal/atrial cerebrospinal fluid catheter | A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where excess CSF causes elevated intracranial pressure (hydrocephalus). 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 | 10381780037224 | GS1 | ||||
| Secondary | M272PC11 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7) |