Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Ultrasonic surgical system tubing set FDA UDI
- Device Name
- 36kHz Manifold Tubing Set Sterile FDA UDI
- Model / Reference
- 40-3601 FDA UDI
- Description
- 36kHz Manifold Tubing Set Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019107737 FDA UDI
- 510(k) Number
- K070360 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Ultrasonic surgical system tubing set FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Ultrasonic surgical system tubing set
Kirwan by Kirwan Surgical Products Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasonic surgical system tubing set.
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- Disposable irrigation/aspiration tubing for I/A, Phaco and Vitrectomy procedures — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Disposable I/A silicone replacement Tubing set for REF: 6279.ASD1 Cartridge, inc — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · U
Cleared under the same submission
K070360 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 U | Pending data |
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Manufacturer
- Manufacturer
- Kirwan Surgical Products Llc
Sources (1)
- FDA UDI 46aba8c6-aa83-4c90-b458-115790400012 35 fields · synced May 30, 2026