FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN®
DI: 10381780511540
·
Model: 161055
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- CODMAN®
- Primary DI
- 10381780511540
- Version / Model
- 161055
- Catalog Number
- 16-1055
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-04-01
- Public Version
- 5
- Public Version Date
- 2023-04-14
- Public Version Status
- Update
- Public Device Record Key
- 73bc7522-812c-43f6-900d-2e36b838912c
Device Description
CODMAN® SOOTT Ventricular Cannula Disposable 8Fr. 1.3mm I D x 2.5mm O D 80mm
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 |
|---|---|---|---|---|
| HCA | CATHETER, VENTRICULAR | Neurology | 882.4100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61854 | Intracerebral cannula, nonimplantable, reusable | A nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00381780511543 | GS1 | ||||
| Primary | 10381780511540 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K834477 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French | |
| Device Size Text, specify | 1.3mm Inner Diameter | ||
| Outer Diameter | 2.5 | Millimeter | |
| Length | 80 | Millimeter |