FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Atrial Catheter
DI: 10381780035817
·
Model: 9MZ100
·
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Atrial Catheter
- Primary DI
- 10381780035817
- Version / Model
- 9MZ100
- Catalog Number
- 9MZ100
- 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
- 5
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- 5f9868b2-e23f-4cf0-8db1-9cae00100da2
- Distribution End Date
- 2021-12-31
Device Description
The Atrial Catheter is used to drain cerebrospinal fluid from the outlet of the valve unit into the right atrium of the heart. The distal end of the catheter does not have any slits.
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 | 10381780035817 | GS1 | ||||
| Secondary | M2729MZ1001 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K861377 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 46cm Length x 2.1mm O.D. x 1.1mm I.D. (F6) |