FDA UDI
In Commercial Distribution
🇺🇸 United States
CODMAN® BACTISEAL®
DI: 10381780524069
·
Model: NS0339
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CODMAN® BACTISEAL®
- Primary DI
- 10381780524069
- Version / Model
- NS0339
- Catalog Number
- NS0339
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-01
- Public Version
- 6
- Public Version Date
- 2023-04-14
- Public Version Status
- Update
- Public Device Record Key
- 76d651bf-d70f-4136-ae8d-fb56b9d4d640
Device Description
CODMAN® BACTISEAL® Clear with Barium Stripe Distal Catheter 120cm, Includes: Information Manual
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 |
|---|---|---|---|---|
| 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 | 10381780524069 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031123 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 120 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 81 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 81 Degrees Fahrenheit