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SuperFlow Tubing Set with EndoSI Suction / Irrigator
FDA UDIClass II (US FDA UDI)
by Armm Inc.
Identity
- Trade Name
- SuperFlow Tubing Set with EndoSI Suction / Irrigator FDA UDI
- Generic Name
- Laparoscopic irrigation/aspiration cannula FDA UDI
- Device Name
- Suction / Irrigation Probe with Wye Tubing Set FDA UDI
- Model / Reference
- 21432 FDA UDI
- Description
- Suction / Irrigation Probe with Wye Tubing Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850082007087 FDA UDI
- 510(k) Number
- K923201 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laparoscopic irrigation/aspiration cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Category: Laparoscopic irrigation/aspiration cannula
SuperFlow Tubing Set with EndoSI Suction / Irrigator by Armm Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laparoscopic irrigation/aspiration cannula.
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- CHOLE KIT 2 — APPLIED MEDICAL RESOURCES CORP. · Class II
- DR. MEHTA-LAP CHOLE — APPLIED MEDICAL RESOURCES CORP. · Class II
- KIT KE214 COLE — APPLIED MEDICAL RESOURCES CORP. · Class II
Cleared under the same submission
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
- Armm Inc.
Sources (1)
- FDA UDI f3528458-5c9c-4594-b64f-0e1b15876397 35 fields · synced May 30, 2026