Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- Reusable I/A Handpiece, Straight Tip FDA UDI
- Model / Reference
- 13-5000 FDA UDI
- Description
- Reusable I/A Handpiece, Straight Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019103432 FDA UDI
- 510(k) Number
- K930113 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical irrigation/aspiration handpiece, reusable
Kirwan by Kirwan Surgical Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical irrigation/aspiration handpiece, reusable.
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- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Accu-Beam — Transamerican Technologies International · Class II
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Cleared under the same submission
K930113 also covers:
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Walcott Rx — Walcott Rx Product Inc
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 I | Pending data |
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Manufacturer
- Manufacturer
- Kirwan Surgical Products Llc
Sources (1)
- FDA UDI fa312f96-91a8-4727-94b9-9c2b9b258e99 35 fields · synced Jun 1, 2026