Identity
- Trade Name
- Modulap FDA UDI
- Generic Name
- Laparoscopic irrigation/aspiration cannula FDA UDI
- Device Name
- ASU1236T Laparoscopic irrigation/aspiration cannula; 5mm x33cm w.o. holes, reusable FDA UDI
- Model / Reference
- ASU1236T FDA UDI
- Description
- ASU1236T Laparoscopic irrigation/aspiration cannula; 5mm x33cm w.o. holes, reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817428020028 FDA UDI
- 510(k) Number
- K982445 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
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: Laparoscopic irrigation/aspiration cannula
Modulap by Atc Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic irrigation/aspiration cannula.
- CHOLE KIT 9 — APPLIED MEDICAL RESOURCES CORP. · Class II
- MicroLap Irrigation Tube Dolphin L=200MM — Medica Corp. · Class II
- CHOLE KIT 24 — APPLIED MEDICAL RESOURCES CORP. · Class II
- PTFE coated cannula Ø 5 mm, 450 mm for irrigation/suction system, single use — Medica Corp. · Class II
- KIT KE201 COLE — APPLIED MEDICAL RESOURCES CORP. · Class II
- 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
K982445 also covers:
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES INC.
- Modulap — ATC TECHNOLOGIES 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atc Technologies Inc.
Sources (1)
- FDA UDI 5d026048-3a6b-4e52-8d09-6f78df29608a 34 fields · synced May 30, 2026