FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN®
DI: 10381780542247
·
Model: 9190001GF
·
Integra LifeSciences Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- CODMAN®
- Primary DI
- 10381780542247
- Version / Model
- 9190001GF
- Catalog Number
- 9190001GF
- Company Name
- Integra LifeSciences Switzerland Sàrl
- Labeler DUNS
- 480186617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2026-04-15
- Public Version
- 1
- Public Version Date
- 2026-04-23
- Public Version Status
- New
- Public Device Record Key
- c8186d92-b208-4eca-82e9-ee784c310eb4
Device Description
CODMAN® Integrated Bipolar Cord and Tubing Set Fixed Leads, Gravity Feed
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 |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61798 | Ventricular cerebrospinal fluid drainage catheterization kit | A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00381780540635 | GS1 | ||||
| Previous | 10381780521730 | GS1 | ||||
| Primary | 10381780542247 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163106 | 000 |