FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ASSURANT® COBALT
DI: 00613994931252
·
Model: ASC660SV
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASSURANT® COBALT
- Primary DI
- 00613994931252
- Version / Model
- ASC660SV
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 5
- Public Version Date
- 2021-12-01
- Public Version Status
- Update
- Public Device Record Key
- 68fb05cb-c539-4f95-a4f0-85a8c73120fa
- Distribution End Date
- 2019-10-21
Device Description
Stent ASC660SV AssrntCo 6mmx60mmx80cm
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIO | STENT, ILIAC | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44279 | Iliac artery stent, bare-metal | A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994931252 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Stent Inner Diameter 6 MM | ||
| Length | 60.0 | Millimeter |