Identity
- Trade Name
- Modulap FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- 4191 Modulap Mono Polar Electrode Probe, 5mm X 45cm, Blunt Tip, Disposable FDA UDI
- Model / Reference
- 4191 FDA UDI
- Description
- 4191 Modulap Mono Polar Electrode Probe, 5mm X 45cm, Blunt Tip, Disposable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817428020967 FDA UDI
- 510(k) Number
- K983623 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
Similar devices
Also classified as Endoscopic electrosurgical electrode, monopolar, single-use.
- Bowel Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
- USA Elite — Gyrus Acmi, Inc. · Class II
- Dorsey Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- 5mm x 10mm Foam Sleeves — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- CleanCoat — Covidien LP · Class II
- Stainless Steel Cardiac 2 Finger Heart Retractor - Large — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
Cleared under the same submission
K983623 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 64d4ecaa-0221-496f-b27f-77e52fc32eeb 34 fields · synced May 30, 2026