FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04038653364008
·
Model: FE932K
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04038653364008
- Version / Model
- FE932K
- Catalog Number
- FE932K
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 2f82642d-3c66-4553-a9af-fc7c19c6b387
- Distribution End Date
- 2017-02-05
Device Description
AVM MICROCLIP PHYNOX CURVED 2MM
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
- 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 | 04038653364008 | GS1 | ||||
| Unit of Use | 04038653386444 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Usable Length of the Jaw : 2.000 MM | ||
| Device Size Text, specify | Material : phynox |