Identity
- Trade Name
- NOIR FDA UDI
- Generic Name
- Aneurysm clip applier FDA UDI
- Device Name
- YASARGIL NOIR Clip Applier Forceps, adjustable, 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
- FT530B FDA UDI
- Description
- YASARGIL NOIR Clip Applier Forceps, adjustable, 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
- FT530B FDA UDI
- Primary DI / UDI-DI
- 04046964725807 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
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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 |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI ed8dd5c3-2031-4bd7-9e12-58f9c7530f29 36 fields · synced Jun 1, 2026