Model: 2901-125L
Catalog: 2901-125L
DI: 00192896123410
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Biopsy Cup With Thorn Double Action Jaws
Sterilization
Method Types - Sterilization Method:
Dry Heat Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b964a357-bfe7-48f2-af2d-1be85998d710
Distribution Status:
In Commercial Distribution
DUNS Number:
040729840
Device Count:
1
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00192896123410
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62061
Name: Endoscopic electrosurgical electrode, monopolar, reusable
Definition:
An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.
FDA Product Codes
GEI
Electrosurgical, cutting & coagulation & accessories
Premarket Submissions
Submission Number:
K102921
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
450
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
5.0
Item #2 - Size Type:
Outer Diameter
Item #3 - Size Text:
Jaw Length 8.0 Millimeter
Item #3 - Size Type:
Device Size Text, specify