Identity
- Trade Name
- NOIR FDA UDI
- Generic Name
- Aneurysm clip applier FDA UDI
- Device Name
- YASARGIL NOIR Clip Applier Forceps, straight, 8 3/4", (220 mm), working length: 3 1/2", (90 mm), bayonet-shaped, narrow pattern, with ratchet, stainless steel, black, non-sterile, reusable FDA UDI
- Model / Reference
- FT522B FDA UDI
- Description
- YASARGIL NOIR Clip Applier Forceps, straight, 8 3/4", (220 mm), working length: 3 1/2", (90 mm), bayonet-shaped, narrow pattern, with ratchet, stainless steel, black, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- FT522B FDA UDI
- Primary DI / UDI-DI
- 04046964725838 FDA UDI
- 510(k) Number
- K211572 FDA UDI
- FDA Product Code
- HCI FDA UDI
- GMDN Term
- Aneurysm clip applier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Aneurysm clip applier
Noir by Aesculap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aneurysm clip applier.
- LAZIC — Peter Lazic GmbH · Class II
- LAZIC — Peter Lazic GmbH · Class II
- Sugita Titanium Clip II Applier — MIZUHO CORPORATION · Class II
- LAZIC — Peter Lazic GmbH · Class II
- LAZIC — Peter Lazic GmbH · Class II
- Sugita Titanium Clip II Single Shaft Applier — MIZUHO CORPORATION · Class II
- Sugita AVM Microclip II Single Shaft Applier — MIZUHO CORPORATION · Class II
- LAZIC — Peter Lazic GmbH · Class II
Cleared under the same submission
K211572 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI c5ce46a2-6b48-4400-9e0e-fe227698f5e7 36 fields · synced May 30, 2026