FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TALENT® OCCLUDER
DI: 00763000233716
·
Model: OCL08US
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TALENT® OCCLUDER
- Primary DI
- 00763000233716
- Version / Model
- OCL08US
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-18
- Public Version
- 9
- Public Version Date
- 2025-09-24
- Public Version Status
- Update
- Public Device Record Key
- 0e54d4e0-fa2a-4680-bb0a-d0ef6e54c4a3
- Distribution End Date
- 2024-08-29
Device Description
STENT GRAFT OCL08US 8MM OCCLUDER
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46777 | Aortoiliac endovascular stent-graft | A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000233716 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100021 | 058 |
| P100021 | 083 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Stent Graft Covered Length 31 MM | ||
| Device Size Text, specify | Stent Graft Diameter 8 MM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature in a dark, dry place