FDA UDI
In Commercial Distribution
🇺🇸 United States
AxiumTM
DI: 00847536017474
·
Model: QC-2-8-HELIX
·
Micro Therapeutics, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AxiumTM
- Primary DI
- 00847536017474
- Version / Model
- QC-2-8-HELIX
- Company Name
- Micro Therapeutics, Inc.
- Labeler DUNS
- 826110710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-07
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 8bb64064-b0e7-4ee1-97a3-374cfb9c257a
Device Description
QC-2-8-HELIX BARE AXIUM 2MM X 8CM
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KRD | Device, Vascular, for Promoting Embolization | Cardiovascular | 870.3300 | 2 |
| HCG | DEVICE, NEUROVASCULAR EMBOLIZATION | Neurology | 882.5950 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60940 | Neurovascular embolization coil | A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00847536017474 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081465 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry cool place not to exceed 50 degrees Celsius