Identity
- Trade Name
- Modulap FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- 3548 Laparoscopic irrigation/aspiration cannula; 5mm x 45 cm with holes, retractor tip style, disposable FDA UDI
- Model / Reference
- 3548 FDA UDI
- Description
- 3548 Laparoscopic irrigation/aspiration cannula; 5mm x 45 cm with holes, retractor tip style, disposable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817428021381 FDA UDI
- 510(k) Number
- K982445 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use 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: Endoscopic electrosurgical electrode, monopolar, single-use
Modulap by Atc Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Atc Technologies Inc.
Sources (1)
- FDA UDI 96eb38a3-acaa-48b8-b350-ad1a00cbfb66 34 fields · synced Jun 7, 2026