Device
BIOP FRCP 3X6MM 110 DEG VERT
Manufacturer
Bausch & Lomb Incorporated
Model: N2935 V Catalog: N2935 V DI: 00757770508846 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
BIOP FRCP 3X6MM 110 DEG VERT
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 66f262c2-9e6c-48fd-a663-2785740eec81
Distribution Status: In Commercial Distribution
DUNS Number: 196603781
Device Count: 1
DM Exempt: Yes
Premarket Exempt: Yes
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: No
Identifiers
Device ID: 00757770508846
Type: Primary
Issuing Agency: GS1
GMDN
Code: 36199
Name: ENT soft-tissue cutting forceps
Definition:
A hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.
FDA Product Codes
KAE
Forceps, Ent