FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN® HOLTER® SALMON™-RICKHAM®
DI: 10381780524809
·
Model: NS0625
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CODMAN® HOLTER® SALMON™-RICKHAM®
- Primary DI
- 10381780524809
- Version / Model
- NS0625
- Catalog Number
- NS0625
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-02
- Public Version
- 4
- Public Version Date
- 2023-05-16
- Public Version Status
- Update
- Public Device Record Key
- 351e7191-9a58-4f98-a65e-6478e584f9aa
Device Description
CODMAN® HOLTER® SALMON-RICKHAM™ Reservoir With Stainless Steel Base for 6mm Burr Hole
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 61375 | Cranial port/reservoir | A sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780524809 | GS1 | ||||
| Previous | 10886704071938 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Use if Package is Damaged