FDA UDI
In Commercial Distribution
🇺🇸 United States
SUGITA TITANIUM ANEURYSM CLIP II
DI: 04946329137705
·
Model: 17-001-34
·
MIZUHO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SUGITA TITANIUM ANEURYSM CLIP II
- Primary DI
- 04946329137705
- Version / Model
- 17-001-34
- Catalog Number
- 17-001-34
- Company Name
- MIZUHO CORPORATION
- Labeler DUNS
- 690677802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-10
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 5da1c3ce-98a8-4204-9694-f443cebe067f
Device Description
TYPE: FENESTRATED, PERMANENT, No.34 RANGE: 139-161gf(1.36-1.58N) MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2 BLADE: BENT MAXIMUM OPENING: 10mm GRIP SURFACE: SERRATED
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HCH | Clip, Aneurysm | Neurology | 882.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34958 | Aneurysm clip | A metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04946329137705 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Millimeter |