Device
Valleylab Tungsten Loop 4”, 10mm x 10mm
Manufacturer
ASPEN SURGICAL PRODUCTS, INC.
Model: E15594 Catalog: E15594 DI: 00840113244232 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Description
Valleylab Tungsten Loop 4”, 10mm x 10mm
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 456eda11-97fa-4107-8366-551d1834fff4
Distribution Status: In Commercial Distribution
DUNS Number: 027680821
Device Count: 10
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Device ID: 00840113242993
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00840113244232
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Device ID: 10607151009912
Item #3 - Device ID Type: Previous
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 61874
Name: Open-surgery electrosurgical electrode, monopolar, single-use
Definition:
An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.
FDA Product Codes
HGI
Electrocautery, Gynecologic (And Accessories)