Maryland Jaw Sealer/Divider
N/A - LF1737
Device Description
A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a previously used single-use device that has been processed for an additional single-use patient application.
Environmental Conditions
- 90.00
- 15.00
- 60.00
- -18.00
Device Sizes
- Diameter: 5.0 Millimeter
- Length: 37.0 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NUJ
Device Name: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class: 2
Physical State: N/A
Definition: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.4400
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 57613327375812
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613327375817
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: case
Device Id: 07613327375817
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A