FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04038653327409
·
Model: FE495K
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04038653327409
- Version / Model
- FE495K
- Catalog Number
- FE495K
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 5630c998-f701-4777-82fa-6fe1cc00eed0
Device Description
YASARGIL XS Clip Applier Forceps, 8 3/4", (220 mm), working length: 3 1/2", (90 mm), bayonet-shaped, with ratchet, standard, phynox
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| HCI | APPLIER, ANEURYSM CLIP | Neurology | 882.4175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32591 | Aneurysm clip applier | A surgical instrument designed for the application/insertion of aneurysm clips (devices for approximating the edges of the neck of an aneurysm or for the prevention of bleeding from small individual blood vessels). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653327409 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Working length (mm) : 90.000 MM | ||
| Device Size Text, specify | Length : 230.000 MM |