FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ANEUROPLASTIC
DI: 10886704015512
·
Model: 43-1290
·
Cerenovus, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANEUROPLASTIC
- Primary DI
- 10886704015512
- Version / Model
- 43-1290
- Catalog Number
- 431290
- Company Name
- Cerenovus, Inc.
- Labeler DUNS
- 607846297
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-20
- Public Version
- 7
- Public Version Date
- 2023-09-15
- Public Version Status
- Update
- Public Device Record Key
- c01cd4c9-4856-4f18-a98a-d9abeaf9c349
- Distribution End Date
- 2022-09-01
Device Description
Codman ANEUROPLASTIC Resinous Material for Reinforcing and Encapsulating Cerebral
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
- No
- 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 |
|---|---|---|---|---|
| JXH | METHYL METHACRYLATE FOR ANEURYSMORRHAPHY | Neurology | 882.5030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33511 | Intracerebral aneurysm repair substance | An implantable adhesive substance (e.g., a glue or a resin) intended to be used in the repair of an intracerebral aneurysm by means of obliterative adhesion of the sac. It is typically used when conservative management, removal, or obliteration by aneursym clip is not clinically indicated. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886704015512 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from Sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Flammable
- Type
- Handling Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius