FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN® BACTISEAL®
DI: 10381780525370
·
Model: NS5091
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CODMAN® BACTISEAL®
- Primary DI
- 10381780525370
- Version / Model
- NS5091
- Catalog Number
- NS5091
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-20
- Public Version
- 1
- Public Version Date
- 2024-11-28
- Public Version Status
- New
- Public Device Record Key
- cb7cd7c3-92a8-4e71-8ae1-b0d433fd6035
Device Description
CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1), Connector (1), Cap (1), Catheter Anchoring Clip (1); Additional Contents: Trocar (1), Stylet (1)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 61399 | Intracerebral infusion/drainage catheter, short-term | A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780525370 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233448 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 35 | Centimeter | |
| Catheter Inner Diameter | 1.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged, Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 81 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 81 Degrees Fahrenheit