FDA UDI
In Commercial Distribution
🇺🇸 United States
EXTENSION
DI: 04547327083577
·
Model: AG149001
·
ASAHI INTECC CO., LTD.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- EXTENSION
- Primary DI
- 04547327083577
- Version / Model
- AG149001
- Company Name
- ASAHI INTECC CO., LTD.
- Labeler DUNS
- 690711189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-24
- Public Version
- 1
- Public Version Date
- 2020-04-01
- Public Version Status
- New
- Public Device Record Key
- bab64bea-7486-40ad-aca9-5cafb03db800
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 |
|---|---|---|---|---|
| DQX | Wire, guide, catheter | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48137 | Coronary artery guidewire extension | A long, thin, sterile wire designed to provide the necessary length to allow the exchange of one coronary artery dilatation catheter for another, while maintaining the position of the cardiac catheter guidewire in the coronary artery, during angiography or percutaneous transluminal coronary angioplasty (PTCA). It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and supplied with a guidewire extension insertion device to facilitate its joining to the proximal end of the in situ guidewire. After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device. | No | Active |
| 61281 | Peripheral vascular guidewire extension | A long, thin, sterile wire designed to provide the necessary length to allow the exchange of a catheter, or other interventional device, while maintaining the intravascular position of the catheter guidewire during an interventional procedure in the peripheral vasculature. It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and is supplied with a connector (e.g., self-locking taper) to facilitate its joining to the proximal end of the in situ guidewire to create the extension (e.g., 150 mm). After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14547327083574 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04547327083577 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.014 | Inch | |
| Length | 165 | Centimeter |